Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods

ABSTRACT

A substance dispensing apparatus comprises a housing for handheld use and a mouthpiece coupled to the housing. The housing comprises a biometric sensor and a cavity sized to receive a reservoir. The mouthpiece comprises a recess and a capacitive sensor array. The apparatus further comprises a pump coupled to the mouthpiece and couplable to the reservoir and comprises a processor in communication with the biometric sensor, capacitive sensor array, and pump. The processor is configured to cause the pump to automatically dispense a substance from the reservoir to a mouth of an intended user via the mouthpiece in response to determining that: a unique biometric attribute of the intended user is detected by the biometric sensor based on biometric data from the biometric sensor; and a unique dentition of the intended user is positioned within the recess of the mouthpiece based on dentition data from the capacitive sensor array.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 16/597,730, now U.S. Pat. No. 11,412,983, filedOct. 9, 2019, which is a divisional application of U.S. patentapplication Ser. No. 15/958,809, now U.S. Pat. No. 10,441,509, filedApr. 20, 2018, which claims priority to and the benefit of the U.S.Provisional Patent Application No. 62/644,145, filed Mar. 16, 2018, eachof which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to pharmaceutical oral doseadministration devices and computerized oral prescription administration(COPA) devices. For example, capacitance sensor(s), environmentalsensor(s), and biometric sensor(s) can be implemented in COPA devicesfor sensing the position of a patient's dentition, sensing when the COPAdevice is inside the patient's mouth, and/or sensing biometricattributes of the patient.

Introduction

The history of pharmacology has produced a continual evolution of routesof administration, pharmaceutical formulations, dosage forms, and dosingdevices in a continuing quest towards maximizing the effective benefitand relative costs of prescription medications. Administration ofprescribed substances may begin in controlled healthcare settings, forexample, at a healthcare facility or by a physician at a patient's home.Early-stage formulations may include liquid forms for parenteral (e.g.,into a blood stream) and enteral (e.g., into a gastro-intestine)administration including elixirs, tonics, solutions, suspensions, syrupsand eventually injections, intravenous (IVs), and epidurals. Theearly-stage formulations may be developed to produce advanced forms, forexample, via mechanization and formulation research. The early-stageformulations, the advanced forms, and further research and clinicalstudies such as patient acceptances of the early-stage formulationsand/or the advanced forms may contribute to the routes ofadministration, pharmaceutical formulations, dosage forms, and dosingdevices.

As the healthcare treatment transitioned from limited emergencyinvolvement into longer term chronic illness care, higher percentages ofthe prescribed medication administration shifted from the controlledhealthcare settings to patient managed settings. In a patient managedsetting, outside the control of a trained healthcare staff, theadministration of liquid formulations may be difficult due tonon-specific dosing instructions. Dosing based on teaspoon and/ortablespoon measurements may be vague and variable. Dosing cups may havedifferent measurement formats, and thus may cause confusion in a patientmanaged setting. In addition, dosing cups are often separated frominitial prescription bottles, and thus may lead to erroneousadministration.

The advancements of mechanical manufacturing systems and pharmacologyresearch enabled patient managed administrations of prescribedsubstances to shift from liquid formulations to pills (e.g., tablets orcapsule-formulations), which may have increased shelf life and allow forpatient ease of use, dosing exactness, and production cost reductions.Thus, a majority of oral medications in patient managed settings are nowpills. Additionally, there is an increased interest in microparticulateformulations including pellets, granules, micro particles, mini tablets,and the like. However, patients, such as infants, elderly, or impairedpatients, that cannot or prefer not to swallow tablets orcapsule-formulations may be given enteral oral liquid prescriptionsthrough dosing syringes in patient managed settings. In addition,parenteral liquid formulations are still commonly administered incontrolled healthcare settings since the parenteral liquid formulationsoften have the fastest rate of absorption and the most expedient successin the desired result and can improve localized administration,inventory control, fraud prevention, and administration path auditcapability.

Depending on the entity managing the administration of a drug, variousforms of the drug may be developed to meet expectations, needs, andchallenges of different entities. While there are some exceptions basedon effectiveness and toxicity, most pharmaceutical manufacturers mayproduce multiple formulations of drugs to support different routes ofadministration and dosing.

There is a growing demand for drug administration in patient controlledor managed settings as consumers increasingly engage in preventative orresultative treatment plans, which involve drug administration inpatient controlled settings. For example, outpatient surgeries and/orone-day inpatient surgery stays are increasingly common for significantmedical procedures, which may involve subsequent drug administrations ata patient's home. In addition, as the population ages, the demand forprescription management increases. Consumers may take multipleover-the-counter and/or prescribed medicines daily, where the medicinesare commonly in the form of pills. Unfortunately, the ease-of-use ofpills and the increasing number of consumers engaged in chronic patientmanaged treatment plans has led to misuse and mismanagement of many drugclasses.

For example, pill forms are lightweight, portable, recipientnon-specific, difficult for inventory management, don't carry individualidentification numbers, have extensive shelf life, and are inexpensiveto produce. Thus, the intakes or usages of pills are difficult tocontrol once outside of healthcare managed environments. In addition, toachieve the economy of scale in the manufacturing process, pillproduction is scheduled based on maximizing the output of the machines,materials, and/or ingredients available instead of based on futuredemands. With a few exceptions, a minimal amount of the pills producedare wasted since pills remain active for a long time. Pills proliferateour society and have become conduits to addiction and abuse.

One such patient managed treatment that is highly susceptible toprescription misuse and mismanagement is opioid pain treatment. Forexample, according to the Food and Drug Administration (FDA),approximately 100 million people in the United States (US) suffer frompain in a given year. About 9 to 12 million of the pain sufferers havechronic or persistent pain, while the remaining pain sufferers haveshort-term pain from injuries, illnesses, or medical procedures. In2014, the Centers for Disease Control and Prevention reported that thenumber of annual opioid prescriptions in the US is about equal to thenumber of adults in the US population. While pain sufferers shouldbenefit from skillful and appropriate pain management, the misuse oraddiction of opioids needs to be controlled. FDA leaders and physiciansattempt to address the opioid epidemic by balancing two complementaryprinciples: deal aggressively with opioid misuse and addiction whileprotecting the well-being of people experiencing acute or chronic pains.However, the pain sufferers in areas where reforms, policies, andrestrictions aimed at opioid misuse have been implemented may notexperience the balance. Some states have implemented additional knownaddict or misuser databases that must be checked by providers prior toprescribing. However, physicians may not check the databases prior toprescribing due to the burden of using the systems and/or they may notwant to restrict access by true chronic pain sufferers. Other stateshave implemented reporting and audit trails to track physicians thathave prescribed from the opioid family. However, to avoid the additionalsteps and potentials for audit scrutiny, some physicians may refuse tooffer pain management or short-term pain prescriptions, and may referall cases to pain clinics.

Attempts at improved patient education, enhanced labeling, andrestrictive prescribing have led to higher costs for providers,patients, pharmacies, and insurance companies and less overalleffectiveness for the patients. In the end, true pain sufferers struggleto have access to opioids while opioid misusers continue to manipulatethe available avenues for access regardless of the apparent oversightsput in place. Policies and plans at various levels have not beensuccessful and are not sufficient to control or reduce the misuse ofprescription drugs. Accordingly, improved devices, systems, and methodsfor drug administration are needed.

SUMMARY

The following summarizes some aspects of the present disclosure toprovide a basic understanding of the discussed technology. This summaryis not an extensive overview of all contemplated features of thedisclosure, and is intended neither to identify key or critical elementsof all aspects of the disclosure nor to delineate the scope of any orall aspects of the disclosure. Its sole purpose is to present someconcepts of one or more aspects of the disclosure in summary form as aprelude to the more detailed description that is presented later.

The present disclosure provides computerized oral prescriptionadministration (COPA) devices, systems, and methods with capacitivedentition sensing, environmental sensing, and refill and dosagemanagement. These COPA devices, systems, and methods facilitate thecontrolled dispensing of medication to an intended user. In this regard,the identification of the intended user can be verified based on acapacitive map of the user's dentition before dispensing the medication.The capacitive map can be detected by a capacitive sensor array coupledto or embedded in a mouthpiece that is positioned inside the intendeduser's mouth. Additionally, environmental sensor(s) can detect whetherthe COPA device is positioned within the intended user's mouth.Additional verification devices, systems, and methods may also be usedto authenticate the intended user. For example, a biometric sensor maybe used to detect a biometric attribute of the intended user, such asthe intended user's fingerprint, to authenticate the intended user.Parameters associated with the dispensing of medication (e.g.,medication, dosage amount, timing, intended user information, etc.) canbe tracked, stored in a COPA management system, and/or communicatedthroughout the healthcare continuum, including medical personnel,pharmaceutical personnel, patient, authorized caregivers, and/orinsurers, such that patient's compliance with a treatment plan can beevaluated and/or the effectiveness of the treatment plan can beevaluated. Additionally, the COPA management system can send out alertsto participants of the healthcare continuum to serve as notices,reminders, and/or issues.

In one embodiment, a substance dispensing apparatus is provided. Theapparatus includes a mouthpiece having a recess and a first capacitivesensor array adjacent to the recess; a processor in communication withthe first capacitive sensor array, the processor configured to determinewhether an intended user's unique dentition is positioned within therecess of the mouthpiece based on input received from the firstcapacitive sensor array; and an actuator in communication with theprocessor, the actuator configured to dispense a substance from areservoir to a mouth of the intended user in response to the processordetermining that the intended user's unique dentition is positionedwithin the recess of the mouthpiece.

In some embodiments, the mouthpiece comprises a first side having afirst outer layer adjacent to the recess, a first intermediate layerpositioned under and in contact with the first outer layer, and a baselayer positioned under and in contact with the first intermediate layer.In some embodiments, the first outer layer comprises a capacitivematerial. In some embodiments, the mouthpiece further comprises a secondside having a second outer layer adjacent to a second recess of themouthpiece and a second intermediate layer positioned under and incontact with the second outer layer. In some embodiments, the secondouter layer comprises a capacitive material. In some embodiments, themouthpiece further comprises a second capacitive sensor array adjacentto the second recess, where the second capacitive sensor array isembedded within the base layer. In some embodiments, the second outerlayer is removably coupled to the second intermediate layer. In someembodiments, the base layer is positioned under and in contact with thesecond intermediate layer, the base layer being positioned between thefirst and second intermediate layers. In some embodiments, the firstouter layer is removably coupled to the first intermediate layer. Insome embodiments, the first capacitive sensor array is embedded withinthe base layer.

In some embodiments, the mouthpiece comprises a first side having afirst intermediate layer adjacent to the recess and a base layerconnected to the first intermediate layer. In some embodiments, therecess of the mouthpiece is sized and shaped to receive a plurality ofusers' dentitions, where the plurality of users' dentitions comprisesdifferent sizes. In some embodiments, the first capacitive sensor arrayincludes one or more capacitive sensors. In some embodiments, theprocessor is positioned within the mouthpiece. In some embodiments, theprocessor is spaced from the mouthpiece. In some embodiments, theprocessor is positioned within a computing device spaced from themouthpiece. In some embodiments, the actuator is positioned within themouthpiece. In some embodiments, the actuator is spaced from themouthpiece. In some embodiments, the mouthpiece is coupled to a housing,the actuator being positioned within the housing. In some embodiments,the reservoir is positioned within the mouthpiece. In some embodiments,the reservoir is spaced from the mouthpiece. In some embodiments, thereservoir is a pharmaceutical medication bottle.

In one embodiment, a method of dispensing a substance to an intendeduser is provided. The method includes receiving an input from acapacitive sensor array of a mouthpiece; determining, based on thereceived input, whether an intended user's unique dentition ispositioned within a recess of the mouthpiece; and dispensing a substancefrom a reservoir to a mouth of the intended user in response todetermining that the intended user's unique dentition is positionedwithin the recess of the mouthpiece.

In some embodiments, capacitance data associated with the input receivedfrom the capacitive sensor array is compared to predeterminedcapacitance data associated with the intended user's unique dentition.In some embodiments, the reservoir is positioned outside the mouth, andthe substance is dispensed to the mouth from the reservoir outside themouth. In some embodiments, the reservoir is positioned inside themouth, and the substance is dispensed to the mouth from the reservoirinside the mouth.

In one embodiment, a method of registering a substance dispensingapparatus to an intended user is provided. The method includesreceiving, from a capacitive sensor array of a mouthpiece, an inputassociated with an intended user's unique dentition biting on themouthpiece; and registering, based on the received input, the intendeduser to the mouthpiece.

In some embodiments, the method further comprises storing the receivedinput in memory integrated in the substance dispensing apparatus. Insome embodiments, the received input is representative of a capacitivemap of the intended user's unique dentition. In some embodiments, aplurality of inputs is received to define a range of acceptable matchesassociated with the intended user's unique dentition biting on themouthpiece.

In one embodiment, a substance dispensing apparatus is provided. Theapparatus includes a housing sized and shaped for handheld use, thehousing having at least one wall and a biometric sensor coupled to theat least one wall; a processor in communication with the biometricsensor, the processor configured to determine whether an intended user'sunique biometric attribute is detected by the biometric sensor based oninput received from the biometric sensor; and a pump in communicationwith the processor, the pump configured to dispense a substance from areservoir to a mouth of the intended user in response to the processordetermining that the intended user's unique biometric attribute isdetected by the biometric sensor.

In some embodiments, the biometric sensor is positioned on a first faceof the at least one wall. In some embodiments, the biometric sensor issized and shaped to receive biometric attributes of a plurality ofusers, where the biometric attributes of the plurality of users comprisedifferent sizes. In some embodiments, the reservoir is a pharmaceuticalmedication bottle configured to hold a liquid. In some embodiments, theat least one wall comprises a surface texturing feature to facilitate auser's grip of the housing during the handheld use. In some embodiments,the at least one wall of the housing comprises a bottom wall and anotherwall coupled to the bottom wall.

In some embodiments, the apparatus further comprises a locking mechanismconfigured to securely seal the bottom wall to the another wall when theanother wall is coupled to the bottom wall. In some embodiments, thehousing further comprises a cavity defined by the at least one wall. Insome embodiments, the pump is positioned within the cavity of thehousing. In some embodiments, the apparatus further comprises thereservoir, wherein the reservoir is positioned within the cavity of thehousing. In some embodiments, the housing further comprises a cappositioned above and in contact with the reservoir and a tubular memberconnecting the pump to a mouthpiece positioned outside of the housing,where the cap is connected to the pump via a connecting member. In someembodiments, the processor is coupled to the mouthpiece. In someembodiments, a distal end of the tubular member is connected to aproximal end of the pump, and a proximal end of the tubular member isconnected to the mouthpiece.

In some embodiments, the cap comprises threads, and the reservoircomprises grooves configured to receive the threads to couple the capand the reservoir. In some embodiments, at least one of the cap, theconnecting member, or the tubular member is positioned within the cavityof the housing. In some embodiments, the cap comprises a valve and a diptube positioned below and in contact with the valve, where the valve isconfigured to regulate an amount of the substance disposed within thetubular member and the connecting member. In some embodiments, the diptube extends from a proximal end connected to the valve to a distal endterminating above a base of the reservoir. In some embodiments,substantially all of a length of the dip tube is positioned within thereservoir. In some embodiments, a distal end of the connecting member iscoupled to a proximal end of the valve, and a proximal end of theconnecting member is coupled to a distal end of the pump.

In one embodiment, a method of dispensing a substance to an intendeduser is provided. The method includes receiving an input from abiometric sensor; determining, based on the received input from thebiometric sensor, whether an intended user's unique biometric attributeis detected by the biometric sensor; receiving an input from anenvironmental sensor; determining, based on the received input from theenvironmental sensor, whether a mouthpiece is positioned within a user'smouth; receiving an input from a capacitive sensor array of themouthpiece; determining, based on the received input from the capacitivesensor array, whether an intended user's unique dentition is positionedwithin a recess of the mouthpiece; and dispensing a substance from areservoir to a mouth of the intended user in response to determiningthat the intended user's unique biometric attribute is detected by thebiometric sensor.

In some embodiments, the received input from the biometric sensor isrepresentative of a fingerprint model of the intended user. In someembodiments, a fingerprint model associated with the input received fromthe biometric sensor is compared to a predetermined fingerprint modelassociated with the intended user's unique biometric attribute. In someembodiments, the method further comprises dispensing the substance fromthe reservoir to the mouth of the intended user in response todetermining that the mouthpiece is positioned within the user's mouth.In some embodiments, the method further comprises dispensing thesubstance from the reservoir to the mouth of the intended user inresponse to determining that the intended user's unique dentition ispositioned within the recess of the mouthpiece.

In some embodiments, the method further comprises registering, based onthe received input from the biometric sensor, the intended user to ahousing coupled to the biometric sensor. In some embodiments, the methodfurther comprises storing the received input from the biometric sensorin memory coupled to the housing. In some embodiments, a plurality ofinputs is received to define a range of acceptable matches associatedwith the intended user's unique biometric attribute contacting thehousing. In some embodiments, the method further comprises receiving,from a capacitive sensor array of a mouthpiece, an input associated withan intended user's unique dentition being within the mouthpiece; andregistering, based on the received input from the capacitive sensorarray, the intended user to the mouthpiece. In some embodiments, aplurality of inputs is received to define a range of acceptable matchesassociated with the intended user's unique dentition being positionedwithin the recess of the mouthpiece. In some embodiments, the substanceis dispensed from the reservoir to the mouth of the intended userautomatically in response to determining that the intended user's uniquebiometric attribute is detected by the biometric sensor.

In one embodiment, a method of dispensing a substance to an intendeduser is provides. The method includes receiving an input from abiometric sensor coupled to at least one wall of a housing defining acavity sized and shaped to receive at least a portion of a reservoir,the housing sized and shaped for handheld use; determining, based on thereceived input from the biometric sensor, whether an intended user'sunique biometric attribute is detected by the biometric sensor;receiving an input from a dentition sensing element of a mouthpiece, themouthpiece coupled to the housing; determining, based on the receivedinput from the dentition sensing element, whether an intended user'sunique dentition is positioned within a recess of the mouthpiece; anddispensing, by a pump coupled to the mouthpiece, a substance from thereservoir to a mouth of the intended user in response to determiningthat the intended user's unique biometric attribute is detected by thebiometric sensor.

In some embodiments, the method further comprises receiving an inputfrom an environmental sensor; and determining, based on the receivedinput from the environmental sensor, whether the mouthpiece ispositioned within a user's mouth. In some embodiments, the substance isdispensed from the reservoir to the mouth of the intended user inresponse to determining that the mouthpiece is positioned within theuser's mouth. In some embodiments, the substance is dispensed from thereservoir to the mouth of the intended user in response to determiningthat the intended user's unique dentition is positioned within therecess of the mouthpiece. In some embodiments, the method furthercomprises registering, based on the received input from the biometricsensor, the intended user to the housing; and storing the received inputfrom the biometric sensor in memory coupled to the housing.

In some embodiments, the substance is dispensed from the reservoir,through a cap positioned within the cavity of the housing, and to themouth of the intended user. In some embodiments, the method furthercomprises registering, based on the received input from the dentitionsensing element, the intended user to the mouthpiece. In someembodiments, the dentition sensing element is a capacitive sensor array.In some embodiments, the substance is dispensed from the reservoir tothe mouth of the intended user automatically in response to determiningthat the intended user's unique biometric attribute is detected by thebiometric sensor.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a top perspective view of a computerized oral prescriptionmedication (COPA) device according to embodiments of the presentdisclosure.

FIG. 2 is a bottom perspective view of a COPA device according toembodiments of the present disclosure.

FIG. 3 is a perspective view of a COPA device coupled with apre-packaged micro-pump unit according to embodiments of the presentdisclosure.

FIG. 4 is a perspective view of a COPA device positioned for docking ata docking station according to embodiments of the present disclosure.

FIG. 5 is a perspective view of a COPA device docked at a dockingstation according to embodiments of the present disclosure.

FIG. 6 is a perspective view of a COPA device and a pre-packagedmicro-pump unit positioned for coupling according to embodiments of thepresent disclosure.

FIG. 7 is a cross-sectional view of a COPA device along section line 7-7in FIG. 1 according to embodiments of the present disclosure.

FIG. 8 is a schematic diagram of a micro-pump unit according toembodiments of the present disclosure.

FIG. 9 is a perspective view of a housing according to embodiments ofthe present disclosure.

FIG. 10 is a perspective view of a COPA device coupled to a housing anda pre-packaged micro-pump unit positioned within the housing accordingto embodiments of the present disclosure.

FIG. 11 is a perspective view of a COPA device coupled to a housing anda pre-packaged micro-pump unit positioned for coupling within the COPAdevice according to embodiments of the present disclosure.

FIG. 12 is a perspective view of a COPA device according to embodimentsof the present disclosure.

FIG. 13 is a perspective view of a COPA device coupled to a housingaccording to embodiments of the present disclosure.

FIG. 14 is a perspective view of an interior of a housing according toembodiments of the present disclosure.

FIG. 15 is a cross-sectional view of a housing along section line 15-15in FIG. 14 according to embodiments of the present disclosure.

FIG. 16 is a cross-sectional view of a housing along section line 15-15in FIG. 14 according to embodiments of the present disclosure.

FIG. 17 is a cross-sectional view of a housing along section line 15-15in FIG. 14 according to embodiments of the present disclosure.

FIG. 18 is a cross-sectional view of a top side of a COPA device alongsection line 18-18 in FIG. 1 according to embodiments of the presentdisclosure.

FIG. 19 is a cross-sectional view of a top and bottom side of a COPAdevice along section line 18-18 in FIG. 1 according to embodiments ofthe present disclosure.

FIG. 20 is a cross-sectional view of a bottom side of a COPA devicealong section line 18-18 in FIG. 1 according to embodiments of thepresent disclosure.

FIG. 21 is a cross-sectional view of a top and bottom side of a COPAdevice along section line 18-18 in FIG. 1 according to embodiments ofthe present disclosure.

FIG. 22 is a cross-sectional view of a top side of a COPA device alongsection line 18-18 in FIG. 1 according to embodiments of the presentdisclosure.

FIG. 23 is a cross-sectional view of a top side of a COPA device in adeformed state along section line 18-18 in FIG. 1 according toembodiments of the present disclosure.

FIG. 24 is a cross-sectional view of a top and bottom side of a COPAdevice in a deformed state along section line 18-18 in FIG. 1 accordingto embodiments of the present disclosure.

FIG. 25A is a cross-sectional view of a top side of a COPA device in adeformed state along section line 18-18 in FIG. 1 according toembodiments of the present disclosure.

FIG. 25B is a cross-sectional view of a top side of a COPA device in adeformed state along section line 18-18 in FIG. 1 and with an uppertooth with a structural feature according to embodiments of the presentdisclosure.

FIG. 26 is a schematic diagram of a COPA system according to embodimentsof the present disclosure.

FIG. 27 is a flow diagram of a method of dispensing a substance to anintended user according to embodiments of the present disclosure.

FIG. 28 is a flow diagram of a method of registering a substancedispensing apparatus to an intended user according to embodiments of thepresent disclosure.

FIG. 29 is a flow diagram of a method of dispensing a substance to anintended user according to embodiments of the present disclosure.

FIG. 30 is a flow diagram of a method of registering a substancedispensing apparatus and/or registering a housing to an intended useraccording to embodiments of the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates.

Embodiments of the present disclosure provide mechanisms foradministering enteral oral medications through an ID-specific deviceregistered with a centralized management system. In an embodiment, asubstance dispensing apparatus (e.g., a COPA device) includes amouthpiece including a recess and a capacitive sensor array adjacent tothe recess. The mouthpiece may include a capacitive sensor arrayincluding a plurality of capacitance sensors positioned at variouslocations within the recess. The mouthpiece may include an environmentalsensor coupled to a mouthpiece, such as an environmental sensorpositioned on a face of a wall of the mouthpiece. The mouthpiece mayinclude a micro-pump unit including a processor, a reservoir, anactuator, flow channels, and exit valves. The reservoir may be filledwith prescribed or over-the-counter medications. The processor may be incommunication with the capacitive sensor array and the actuator. Toadminister the medications, the patient may insert the mouthpiece intothe patient's mouth and close the mouth to bite on the mouthpiece. Thecapacitive sensor array may sense and measure the capacitance associatedwith the user's dentition and bite. The processor may determine whethera match is found between the measured capacitance and pre-recorded dataof the intended recipient. The processor may determine whether themouthpiece is positioned correctly. The environmental sensor may senseand measure attributes of the environment (e.g., the temperature)surrounding the mouthpiece. The processor may determine whether themouthpiece is located within the user's mouth. Upon detecting a matchand correct positioning and location, the processor may activate theactuator to release an exact dosage of the medications through the flowchannels and exit valves into the patient's mouth for ingestion. In anembodiment, the centralized management system may track the creation andpreparation of the mouthpiece, the filling of the prescribedmedications, and/or the administration or dispensing of the prescribedmedications through various identification mechanisms.

The disclosed embodiments may provide several benefits. For example, theemployment of the individually registered mouthpiece with the embeddedprocessor and the centralized management system can ensure that theprescribed medications are delivered to the intended recipient. Thus,the disclosed embodiments may avoid misuse and mismanagement ofprescription medications. In addition, the disclosed embodiments mayallow healthcare providers and insurance companies to better track theadministering of the prescribed medications and evaluate the benefits,effects, and/or results of the prescribed medications more accurately.The disclosed embodiments may deliver a precise dosage of prescribedmedications to patients and may especially benefit patients that areelderly, impaired, or have behavioral issues that may limit theirabilities to self-administer prescribed medications. While the disclosedembodiments are described in the context of using a capacitive map as aform of verification for matching a prescription to an intended user,other biological markings (fingerprint, retina or iris scans, DNA, voicerecognition, etc.) may also be applied or used in conjunction withand/or in lieu of the capacitive map. In addition, the employment of acapacitive sensor array can ensure that one mouthpiece may be used forseveral users (with only one intended user registered to the mouthpieceat a time). Thus, the disclosed embodiments may avoid burdensomeproduction costs.

FIG. 1 is a top perspective view of a COPA device 100 according toembodiments of the present disclosure. The COPA device 100 may be usedfor delivering enteral oral liquid, multiparticulate, and/or other formsof drugs to an intended patient or user with controlled dosing. The COPAdevice 100 is a mouthpiece including a top side 102. The top side 102may include a capacitive sensor array in one or more layers forming thetop side. Exemplary arrangements of the one or more layers are describedin FIGS. 18-25B. A top side outer layer of the top side 102 may besubstantially planar. This may allow the COPA device 100 to fit within aplurality of different mouths with a plurality of different dentitions.In some embodiments, the capacitive sensor array may detect a capacitivemap when the user bites down on the top side 102 of the COPA device 100.The capacitive map may be compared to a pre-determined capacitive map ofthe user's dentition as a form of verification to identify an intendedrecipient of a prescribed substance, as described in greater detailherein.

The COPA device 100 may also include a front wall portion 126 and a backwall portion 128. The front and back wall portions 126, 128 extend outfrom the COPA device 100 and define a recess 110. In some embodiments,the front and back wall portions 126, 128 may be perpendicular to a topsurface of a top side outer layer of the COPA device 100. In otherembodiments, the front and back wall portions 126, 128 may be angled(i.e., not perpendicular) relative to a top surface of a top side outerlayer of the COPA device 100. The top side 102 may be configured toreceive a corresponding first portion of the user's dentition (e.g., theuser's upper teeth). Therefore, in some embodiments, the user may placethe user's upper teeth in the recess 110. The recess 110 may be sizedand shaped to receive a plurality of users' dentitions, and theplurality of users' dentitions may comprise different sizes. In someembodiments, the COPA device 100 may also include a cutout portion 130to further accommodate different mouth shapes of different users.Additionally, the COPA device 100 may be constructed from abiocompatible impression material or polymer.

The COPA device 100 further includes a sealed prescription dispensingunit 120. The sealed prescription dispensing unit 120 may be positionedat the top center of the COPA device 100. In some embodiments, thesealed prescription dispensing unit 120 may not be coupled to the COPAdevice 100. The sealed prescription dispensing unit 120 may be locatedin an external housing that may be coupled to the COPA device 100. Thesealed prescription dispensing unit 120 may include a sealed sleeve 124and a plurality of access ports 122 extending from a top side of thesealed sleeve 124 into the prescription dispensing unit 120. The accessports 122 may be configured to receive prescribed substances. Forexample, a clinician or pharmacy technician may fill prescribedsubstances into the prescription dispensing unit 120 via the accessports. The prescribed substances may include formulations in variousforms, such as liquid and/or multiparticulate. The prescriptiondispensing unit 120 may include other components, such as a processor,chambers, flow channels, actuators (e.g., micro-pumps), and exit valves,as described in greater detail herein.

The COPA device 100 may provide patient identification functionalitiesvia the patient's capacitive map as detected by the capacitive sensorarray. For example, each individual has a unique dental imprint, whichcorresponds to a unique capacitive map. While there are certain patternsfor the ages at which certain teeth may erupt, mature, and be replacedwith permanent teeth and for alignment of teeth types, the setting,size, angle, distance between certain points within a patient's mouth,and the resulting bite are different for different patients. Inaddition, damaged teeth, missing teeth, filled teeth, capped teeth, andprosthetics such as crowns, bridges, partial, and full dentures furtherthe identifying nature or uniqueness of the mouths of differentindividuals. Thus, the use of the COPA device 100 with the dentitionimprint corresponding to a unique capacitive map can be effective inidentifying a particular individual. The COPA device 100 may providefurther patient identification functionalities via various patientverification mechanisms implemented by a processor coupled to themouthpiece (e.g., embedded within the sealed prescription dispensingunit 120), as described in greater detail herein.

The COPA device 100 further provides controlled prescriptionadministration functionalities via the sealed prescription dispensingunit 120. For example, the processor may be in communication with thecapacitive sensor array and configured to determine whether the COPAdevice 100 is correctly positioned within the intended user's mouth.Upon detecting a matching capacitive map, the processor may control thecomponents within the sealed prescription dispensing unit 120 to releaseor deliver an exact dosage of the prescribed substances into theintended user's mouth, as described in greater detail herein.

FIG. 2 is a bottom perspective view of the COPA device 100 according toembodiments of the present disclosure. The bottom side 104 may include acapacitive sensor array in one or more layers forming the top side.Exemplary arrangements of the one or more layers are described in FIGS.12-18B. A bottom side outer layer of the bottom side 104 may besubstantially planar. This may allow the COPA device 100 to fit within aplurality of different mouths with a plurality of different dentitions.In some embodiments, the capacitive sensor array may detect a capacitivemap when the user bites on the bottom side 104 of the COPA device 100.The prescription dispensing unit 120 includes a plurality of exit valves222 on the bottom side 104, where prescribed substances may be released.Additionally, in some embodiments, the front and back wall portions 126,128 (FIG. 1 ) extend out from the COPA device 100 and define a recess210. In some embodiments, the front and back wall portions 126, 128 maybe perpendicular to a top surface of a top side outer layer of the COPAdevice 100. In other embodiments, the front and back wall portions 126,128 may be angled (i.e., not perpendicular) relative to a top surface ofa top side outer layer of the COPA device 100. The bottom side 104 maybe configured to receive a corresponding second portion of the user'sdentition (e.g., the user's lower teeth). Therefore, in someembodiments, the user may place the user's lower teeth in the recess210. The recess 210 may be sized and shaped to receive a plurality ofusers' dentitions, and the plurality of users' dentitions may comprisedifferent sizes.

As discussed above, FIG. 1 and FIG. 2 illustrate embodiments of the COPAdevice 100 where the recesses 110, 210 and the front and back wallportions 126, 128 are configured to receive both upper teeth and lowerteeth of a user. In some embodiments, though, the COPA device 100 onlyincludes the recess 110 (see FIG. 18 ). For example, the front and backwall portions 126, 128 may be configured to fit around the user's upperteeth as the user's upper teeth are received in the recess 110. In otherembodiments, the COPA device 100 only includes the recess 210 (see FIG.20 ). For example, the front and back wall portions 126, 128 may beconfigured to fit around the user's lower teeth as the user's lowerteeth are received in the recess 210. In further embodiments (e.g., theembodiments shown in FIG. 1 and FIG. 2 ), the COPA device 100 includesboth of the recesses 110, 210. For example, the front and back wallportions 126, 128 may be configured to fit around the user's upper andlower teeth as the user's upper and lower teeth are received in therecesses 110 and 210, respectively.

FIG. 3 is a perspective view of the COPA device 100 according toembodiments of the present disclosure. FIG. 3 illustrates the COPAdevice 100 with an upper portion of the sealed sleeve 124 (shown in FIG.1 ) removed to provide a more detailed view of the prescriptiondispensing unit 120. As shown, the prescription dispensing unit 120includes a micro-pump unit 300. The access ports 122 may be incommunication with the micro-pump unit 300 to allow prescribedsubstances to be filled into the micro-pump unit 300.

FIG. 4 is a perspective view of the COPA device 100 positioned fordocking at a docking station 400 according to embodiments of the presentdisclosure. FIG. 5 is a perspective view of the COPA device 100 dockedat the docking station 400 according to embodiments of the presentdisclosure. The COPA device 100 may be positioned into the dockingstation 400 for storage, charging, and/or communicating over acommunications network. The docking station 400 may include a dockingcompartment 410, a wireless transceiver 420, a charging component 430, aplurality of indicators 440, and a COPA device sensing component 450.The wireless transceiver 420, the charging component 430, the indicators440, and the COPA device sensing component 450 may be arranged as shownor in any suitable configuration on the docking station 400.

The docking compartment 410 may be sized and shaped to house the COPAdevice 100. The wireless transceiver 420 may be configured to transmitand receive data while the COPA device 100 is docked at the dockingstation 400 via a patient private wireless network, as described ingreater detail herein. The charging component 430 may include a hapticcharging component (e.g., for charging batteries) and may be configuredto charge the COPA device 100 while the COPA device 100 is docked at thedocking station 400. For example, the operations of the processor, theactuators, and the releasing of the prescribed substances operate basedon electrical power. The COPA device sensing component 450 may beconfigured to detect whether the COPA device 100 is docked correctly.For example, the bottom side 104 of the COPA device 100 may furtherinclude a docking station sensing component, where alignment between theCOPA device 100 and the docking station 400 may be detected via the COPAdevice sensing component 450 and the docking station sensing component.After detecting alignment, the charging component 430 may begin tocharge the COPA device 100. In addition, the COPA device 100 may uploadprescription administration activities via the wireless transceiver 420to a COPA management system, as described in greater detail herein. Theindicators 440 may include light-emitting diodes (LEDs). The indicators440 may be configured to indicate whether the COPA device 100 ispositioned correctly within the docking compartment 410 for charging andwireless communications. The indicators 440 may be further configured toindicate the charging status (e.g., power on/off) of the COPA device 100and/or the wireless transmission and/or reception activities of thewireless transceiver 420.

In some embodiments, the docking station 400 provides a closed loopcontrol system that can sense and detect the presence of the COPA device100 at various stages of use and/or storage and provide correspondingfeedback and/or alerts to the user, caregiver, doctor, and/or pharmacy.For example, the indicators 440 may be configured to indicate that theCOPA device 100 is within proximity of the docking station 400, properlydocked within the docking station 400, improperly docked within thedocking station 400, charging, fully charged, transferring data,operating properly, operating improperly, and/or other statusindications. In some embodiments, the docking station 400 may include asound generation component (e.g., a speaker) that can generate varioustones and/or vibrations to indicate a current status, including theproximity or docking of the COPA device 100, charging activities, and/orcommunication activities. In some embodiments, the docking station 400can be in communication with a computing device such as a smartphone,tablet, or computer (e.g., via a wireless transceiver 420 or via a wiredconnection) and may send the feedback and/or alerts (as well as logs ofprescription administration activities obtained from the COPA device100) to a COPA smartphone or tablet application.

The COPA device 100 may be placed in the docking station 400 betweendosages for storage, charging, and/or communication as needed (e.g.,multiple times per day, daily, nightly, weekly, etc.). The chargingand/or power needs of the COPA device 100, including the prescriptiondispensing unit 120, may be minimal since the operations associated withdispensing the medications may typically span short durations (e.g., 1minute or less). In addition to charging and wireless communications,the docking station 400 may help prevent the COPA device 100 from beinglost, misplaced, or damaged. For example, the docking station 400 mayfurther include locking mechanisms to provide additional protocols formatching the COPA device 100 to an intended user. In an embodiment, thedocking station 400 may include a thumbprint or optical scanningcomponent configured to unlock or release the COPA device 100 based on athumbprint verification against the intended user's thumbprint or anyother biological markings.

To prevent a successful matching and unlocking of the COPA device 100 byan unintended user for subsequent release of the prescription, theprocessor within the prescription dispensing unit 120 may be furtherconfigured to limit the activation time for the release of theprescription in conjunction with the locking mechanisms. For example, acharged COPA device 100 may be inserted into a patient's mouth for drugdelivering or releasing at a designated time. When the administering ofthe medication is not time-specific, the controlling of the medicationrelease time may begin after an initial use. For example, the processormay be configured to record the time of the initial use and controlsubsequent releases based on an elapsed time duration or an intervalbetween prescribed dosages. The processor may be configured to releasethe drug at a designated time or designated time durations forsubsequent deliveries.

FIG. 6 is a perspective view of the COPA device 100 and the micro-pumpunit 300 positioned for coupling according to embodiments of the presentdisclosure. The micro-pump unit 300 is the core of the prescriptiondispensing unit 120. The micro-pump unit 300 includes a processor 310, areservoir 320, an actuator 330, and a plurality of exit valves 340. Theprocessor 310 is configured to control the micro-pump unit 300 andrecord activities associated with the COPA device 100, for example,dosage delivery time and amount, charged time, and/or wirelesscommunication activities. The reservoir 320 is configured to hold aprescribed substance, for example, as formulated for delivery via themicro-pump unit 300. The actuator 330 is configured to push or deliveran exact dosage of the prescribed substance upon activation. The exitvalves 340 are positioned at the bottom of the micro-pump unit 300 andare configured to release the prescribed substance for ingestion. Moredetailed views of the micro-pump unit 300 are shown in FIGS. 9 and 10and the interactions among the components of the micro-pump unit 300 aredescribed in greater detail below. The micro-pump unit 300 may bepre-packaged with a prescription through various mechanisms, asdescribed in greater detail herein. As shown, the COPA device 100 mayinclude a compartment 114 sized and shaped to receive the micro-pumpunit 300. For example, the pre-packaged micro-pump unit 300 may bepositioned within the compartment 114 and covered by the sealed sleeve124 (shown in FIG. 1 ) to form the sealed prescription dispensing unit120.

In some embodiments, the processor 310 may be located outside of themicro-pump unit 300. For example, the processor 310 may be removed fromthe micro-pump unit 300, spaced from the micro-pump unit 300, or coupledto the outside of the micro-pump unit 300. In other embodiments, theprocessor 310 may be located outside of the COPA device 100 altogether.For example, the processor 310 may be removed from the COPA device 100,spaced from the COPA device 100, or coupled to the outside of the COPAdevice 100. In exemplary embodiments, the processor 310 may bepositioned in a computing device, such as a phone, a tablet, a computer,a server, or any other suitable computing device. In other embodiments,the processor 310 may be located within the micro-pump unit 300. Forexample, the processor 310 may be coupled to the micro-pump unit 300. Inother embodiments, the processor 310 may be coupled to the COPA device100.

In some embodiments, the processor 310 may communicate with a biometricsensor 550 (FIG. 9 ) via a wired connection. In other embodiments, theprocessor 310 may communicate with the biometric sensor 550 via awireless connection. The processor 310 may receive a signal (e.g., aninput) from the biometric sensor 550. The signal/input may be generatedbased on a physical interaction between the biometric sensor 550 and abiometric attribute of the user (e.g., the user's fingerprint), whichwill be discussed in greater detail with respect to FIG. 9 .

In some embodiments, the processor 310 may communicate with anenvironmental sensor 560 (FIG. 12 ) via a wired connection. In otherembodiments, the processor 310 may communicate with the environmentalsensor 560 via a wireless connection. The processor 310 may receive asignal (e.g., an input) from the environmental sensor 560. Thesignal/input may be generated based on environmental attributes (e.g.,temperature), which will be discussed in greater detail with respect toFIG. 12 .

In some embodiments, the processor 310 may communicate with a top sidecapacitive sensor array 716 (FIG. 18 ) and/or a bottom side capacitivesensor array 718 (FIG. 19 ) via a wired connection. In otherembodiments, the processor 310 may communicate with the top sidecapacitive sensor array 716 and/or the bottom side capacitive sensorarray 718 via a wireless connection. The processor 310 may receive asignal (e.g., an input) from the top side capacitive sensor array 716and/or the bottom side capacitive sensor array 718. The signal/input maybe generated based on deformation of the top side 102 and/or the bottomside 104 of the COPA device 100 (which will be discussed in greaterdetail with respect to FIGS. 23 and 24 ).

In some embodiments, the actuator 330 may be located outside of themicro-pump unit 300. For example, the actuator 330 may be removed fromthe micro-pump unit 300, spaced from the micro-pump unit 300, or coupledto the outside of the micro-pump unit 300. In other embodiments, theactuator 330 may be located outside of the COPA device 100 altogether.For example, the actuator 330 may be removed from the COPA device 100,spaced from the COPA device 100, or coupled to the outside of the COPAdevice 100. In other embodiments, the actuator 330 may be located withinthe micro-pump unit 300. For example, the actuator 330 may be coupled tothe micro-pump unit 300. In other embodiments, the actuator 330 may becoupled to the COPA device 100.

In some embodiments, the reservoir 320 may be located outside of themicro-pump unit 300. For example, the reservoir 320 may be removed fromthe micro-pump unit 300, spaced from the micro-pump unit 300, or coupledto the outside of the micro-pump unit 300. In other embodiments, thereservoir 320 may be located outside of the COPA device 100 altogether.For example, the reservoir 320 may be removed from the COPA device 100,spaced from the COPA device 100, or coupled to the outside of the COPAdevice 100. In other embodiments, the reservoir 320 may be locatedwithin the micro-pump unit 300. For example, the reservoir 320 may becoupled to the micro-pump unit 300. In other embodiments, the reservoir320 may be coupled to the COPA device 100. In some embodiments, thereservoir 320 may be a pharmaceutical medication bottle. For example,the reservoir 320 may be a prescription pill bottle, a liquid painmedication bottle, or any other suitable container (which may becommercially available) to hold prescribed or over-the-countermedications.

FIG. 7 provides a detailed view of the internal components of themicro-pump unit 300 and the interactions among the internal componentsaccording to embodiments of the present disclosure. In this regard, FIG.7 is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong section line 7-7 of FIG. 1 . The micro-pump unit is positionedwithin the compartment 114 (shown in FIG. 6 ) of the COPA device 100.The micro-pump unit 300 may further include a charging component 360(e.g., batteries) and a memory 370 (shown in FIG. 8 ). The chargingcomponent 360 may be in communication with the processor 310 and theactuator 330. When the COPA device 100 is docked at the docking station400 as shown in FIG. 5 , the charging component 360 may be coupled tothe charging component 430 of the docking station 400 and configured tocharge the COPA device 100 (e.g., the processor 310 and the actuator330) via battery charging or wireless charging. The memory 370 mayinclude volatile memory and non-volatile memory of any suitable memorytypes, including random access memory (RAM), read-only memory (ROM),programmable read-only memory (PROM), erasable programmable read-onlymemory (EPROM), electrically erasable programmable read-only memory(EEPROM), dynamic random-access memory (DRAM), static random-accessmemory (SRAM), and combinations thereof. In some embodiments, the memory370 may be coupled to the micro-pump unit 300. In some embodiments, thememory 370 may be disposed within the substance dispensing apparatus(e.g., the COPA device 100). The access opening 134 (FIG. 1 ) may extendthrough the COPA device 100, from an exterior face to an interior face,terminating at an outlet opening that may be within the user's mouth, insome embodiments. In some embodiments, the outlet opening may be withinthe user's mouth when the COPA device 100 is within the user's mouth. Inother embodiments, the outlet opening may be outside of the user'smouth, such as when the COPA device 100 is outside of the user's mouth.The walls of the access opening 134 may define a hollow cavity, and theaccess opening 134 may be a cylinder, a rectangular prism, or any othersuitable shape.

The processor 310 can be in communication with the top side capacitivesensor array 716 and/or the bottom side capacitive sensor array 718, forexample, via the wire 710, and the actuator 330. While only the top sidecapacitive sensor array 716 and the wire 710 is illustrated in FIG. 7 ,it is understood that the processor 310 can be in communication with thebottom side capacitive sensor array 718 via one or more wires (e.g., thewire 710 and/or other wires). The actuator 330 can be in communicationwith the reservoir 320 and the exit valves 340 via flow channels 350.The reservoir 320 can be in communication with the access ports 122(shown in FIG. 1 ) and the flow channels 350.

The reservoir 320 may include one or more chambers 322, for example,one, two, three, four, five, six, or any suitable number of chambers322. The chambers 322 may be configured to hold a prescribed substance720. In this regard, the number and size of the chambers 322 can beselected based on the number of prescribed substances, type(s) ofprescribed substances, and/or dosage amounts to be used. The chambers322 can be any size that will still allow the device to be positionedwithin the mouth of a patient. In some instances, the chambers 322 arein communication with corresponding chambers or channels formed in theCOPA device 100 to allow an increased volume of storage for theprescribed substance(s). The chambers 322 may be in communication withthe access ports 122. In some embodiments, each chamber 322 is incommunication with one of the access ports 122 through access cannulas730.

A clinician or a pharmacy technician may fill or refill the prescribedsubstance 720 via the access ports 122. The prescribed substance 720 mayinclude liquid formulations, powder formulations, multiparticulateformulations, or any other suitable formulations. In some embodiments,all chambers 322 are filled with liquid formulations. In some otherembodiments, one chamber 322 may be filled with a liquid formulation andanother chamber 322 may be filled with a powder or multiparticulateformulation. The prescribed substance 720 in the different chambers 322may be released at the same time to form a particular formulation or atdifferent times to prevent certain active ingredients in the prescribedsubstances 720 from reacting with each other. In this regard, eachchamber 322 may contain a different prescribed substance for theintended user.

The actuator 330 may be a micro-pump suitable for delivery ofpharmaceutical formulations. The actuator 330 may be activated ortriggered by the processor 310 to cause the prescribed substances 720 toflow through the flow channels 350 and exit cannulas 740 and release viathe exit valves 340. The actuator 330 may be activated one or more timesto release an exact dosage of the prescribed substances 720. The flowchannels 350 may be constructed from suitable tubing materials. The exitvalves 340 may be any suitable flow control valves, for example, withelastomeric membranes, configured to prevent leakage of the prescribedsubstances 720 into the user's mouth or backflow of the prescribedsubstance 720 from the user's mouth into the COPA device 100.

The processor 310 may be any suitable microcontroller or microprocessorconfigured to perform the functions described herein, includingfunctions such as performing patient identification and verification,performing capacitance sensing (e.g., in conjunction with the top sideand/or bottom side capacitive sensor arrays), instructing the actuator330 to release a dose of the prescribed substance 720, controlling theopening of the exit valves 340, controlling operation of components ofthe micro-pump unit 300 in accordance with dosage instructions for anintended user, storing dispensing data, etc. The dosage instructions mayinclude at least a dosage amount and timing for dispensing the substanceto the intended user. The dosage instructions may be stored in thememory 370.

FIG. 8 is a schematic diagram of the micro-pump unit 300 according toembodiments of the present disclosure. FIG. 8 provides a more detailedview of the micro-pump unit 300 and interactions with the top side andbottom side capacitive sensor arrays 716, 718 and the docking station400. As shown, the micro-pump unit 300 may further include a wirelesstransceiver 380. The wireless transceiver 380 may implement any suitablewireless communication protocols. The wireless transceiver 380 maywirelessly communicate with the docking station 400, for example, toupload recorded activities or to download revised or new dosageinstructions, as described in greater detail herein. Further, thewireless transceiver 380 may wirelessly communicate with other wirelesscommunication devices, including a communication device (e.g., acomputer, tablet, smartphone, etc.) of the intended user. In thisregard, the processor of the micro-pump unit 300 can be configured toinitiate alerts or reminders to the user (e.g., based on a dosage timingof the dosage instructions) by triggering the intended user'scommunication device to issue such an alert or reminder (e.g., byactivating an audible and/or visual indicator). Similarly, the processorof the micro-pump unit 300 and/or the docking station 400 can beconfigured to initiate alerts or reminders through communications with acommunication device of a medical provider. For example, the micro-pumpunit 300 and/or the docking station may alert the medical provider basedon a failure to dispense the substance in accordance with the dosageinstructions (e.g., the patient is not taking the medication asprescribed) and/or multiple failed attempts to authenticate the intendeduser (e.g., indicating that someone other than the intended user isattempting to access the medication or that the intended user is havingdifficulties using the device).

FIG. 9 provides a perspective view of the housing 500 according toembodiments of the present disclosure. The housing 500 may include anupper portion 510 and a lower portion 520. The housing 500 may be sizedand shaped for handheld use. For example, the housing 500 may bestructurally arranged to be gripped by a single hand of a user byplacing the user's fingers and palm around the housing 500. The housing500 may be any suitable shape such as a cylinder, a rectangular prism, acube, or any combination thereof. In some instances, the housing 500 maybe formed of multiple walls. The housing 500 may include an insidecavity for receiving one or more components, such as a medication bottle590, a cap 592, a dip tube 594, a valve 596, a pump 598, a tubularconnector 580, the tubular member 540, and/or any other suitablecomponents. The inside cavity may be defined by the walls of the housing500. In some embodiments, the housing 500 can be contoured to havecorresponding areas (e.g., depressions and/or raised portions) for theuser's fingers. For example, the housing 500 can be contoured to have agrip disposed on all or a portion of the housing 500. An exteriorsurface of the housing 500 can include surface roughening featuresand/or surface texturing features, such as texturing, knurling, taping,etc. The housing 500 can be made of any suitable material such as apolymer, plastic, metal, metal alloy, etc. For example, the material ofthe housing 500 and/or the exterior surface of the housing 500 may bestructurally arranged to facilitate easy gripping by a user, includingpatients with diminished hand strength, such as elderly patients.

In some embodiments, the housing 500 includes a biometric sensor 550.The biometric sensor 550 may be a fingerprint scanner, an opticalscanner (e.g., a retina scanner, a cornea scanner, an iris recognitionscanner, etc.), a DNA scanner (e.g., a saliva scanner, a perspirationscanner, a sebum (i.e., skin oil) scanner), a camera for detectingfacial features (e.g., feature size, feature geometry, feature spacing,vein spacing, etc.), a voice print scanner, an auditory scanner, anolfactory scanner, a vibration scanner configured to detect a walkingand/or running gait of the user, and/or a scanner enabled to recognizeany other suitable biological marker. The biometric sensor 550 caninclude a camera, electromagnetic sensor, and/or optical sensor devicefor detecting electromagnetic radiation including visible, infrared,and/or ultraviolet light, for example. The electromagnetic sensor maysense reflected, refracted, or detected waves (e.g., visible lightwaves, infrared waves, ultraviolet waves, etc.) and may be used todetect one or more features, such as anatomical features, of the user.In some instances, the housing 500 can include one or more sources ofelectromagnetic radiation, such as an illumination source, to providevisible, infrared, and/or ultraviolet light, for example. In someexamples, the biometric sensor 550 may be a signature verificationdevice, such as an optical scanner, a camera, a digital scanner (e.g., acapacitive touch screen, a resistive touch screen, etc.), and/or anycombination thereof. The signature verification device may scan an imageof the user's signature using, for example, the optical scanner and/orthe camera. In other instances, the signature verification device mayobtain the user's signature in real-time using, for example, the digitalscanner. The housing 500 may include one biometric sensor 550 ormultiple biometric sensors, including the different types of biometricsensors described above.

In an exemplary embodiment, the biometric sensor 550 may be afingerprint scanner that uses an optical sensor or an ultrasonic sensor.The biometric sensor 550 may be sized and shaped to match with thedimensions of a plurality of the user's fingers, or the biometric sensor550 may be sized and shaped to match with the dimensions of only one ofthe user's fingers. For example, the biometric sensor 550 may be sizedand shaped to match with the dimensions of the user's right thumb, rightindex finger, right middle finger, right ring finger, right pinkyfinger, and/or the corresponding fingers on the user's left hand,respectively. In some instances, the biometric sensor 550 may be asubstantially circular shape. In other instances, the biometric sensor550 may be a substantially elliptical shape. The biometric sensor 550may be any other suitable shape. In some embodiments, the biometricsensor 550 may be sized and shaped so that the entire fingerprint of theuser fits within an outside border of the biometric sensor 550. In otherembodiments, the biometric sensor 550 may be sized and shaped so thatonly a portion of the user's fingerprint fits within the outside borderof the biometric sensor 550.

The biometric sensor 550 may be located on the housing 500 in such a waythat is ergonomic for the user. In an exemplary embodiment, the intendeduser holds the housing 500 while the COPA device 100 is in the intendeduser's mouth because the COPA device 100 is coupled to the housing 500(see FIG. 10 ). Therefore, in such embodiments, it is beneficial to theuser to have the biometric sensor 550 located in an ergonomic positionwhen the user is holding the housing 500 so as to reduce strain on theuser's hand, wrist, and/or arm.

In the embodiment in FIG. 9 , the biometric sensor 550 is located on thelower portion 520 of the housing 500. In other embodiments, thebiometric sensor 550 may be located on the upper portion 510 of thehousing 500. Additionally, in the embodiment in FIG. 9 , the biometricsensor 550 is located on a front face 522 of a front wall 524 the lowerportion 520 of the housing 500. For example, the biometric sensor 550may be coupled to the front wall 524, positioned on the surface of thefront wall 524, or positioned partially or fully within the front wall524. The front wall 524 may be coupled to the bottom wall 570 (FIG. 15 )of the housing. The front face 522 of the housing 500 may be a surfacethat faces the user when the user grips and holds the housing 500 in hisor her hand. This arrangement may advantageously permit the biometricsensor 550 to detect the user's thumb when the user's hand is positionedaround the housing 500. In other embodiments, the biometric sensor 550may be located on any other face of the lower portion 520 or any face ofthe upper portion 510 of the housing 500. For example, the biometricsensor 550 may be located on a back face of the lower portion 520 of thehousing 500. This arrangement may advantageously permit the biometricsensor 550 to detect the user's index finger when the user's hand ispositioned around the housing 500. In other instances, this arrangementmay also permit the biometric sensor 550 to detect the user's middlefinger, ring finger, and/or pinky finger when the user's hand ispositioned around the housing 500. In other embodiments, the biometricsensor 550 is not located on the housing 500 at all. For example, thebiometric sensor 550 may be removed from the housing 500 or spaced fromthe housing 500. As an additional example, the biometric sensor 550 maybe located on a phone, tablet, or computer.

In some embodiments, the intended user may place the intended user'sfingerprint on the biometric sensor 550. The biometric sensor 550 thendetects a fingerprint model of the intended user's scanned fingerprint.The detected fingerprint model is unique to the intended user. In otherembodiments, the biometric sensor 550 may detect multiple fingerprintmodels based on multiple inputs. For example, the intended user mayplace the intended user's fingerprint on the biometric sensor 550 indifferent orientations, directions, and/or locations. As an example, theintended user may place between 50% and 75% of the intended user'sfingerprint on the biometric sensor 550. The above range of percentagesis listed for exemplary purposes only. Percentages of less than 50% ofthe intended user's fingerprint and greater than 75% of the intendeduser's fingerprint are also contemplated by the present disclosure. Thebiometric sensor 550 may detect multiple fingerprint models based on themultiple inputs discussed above in order to define a range of acceptablefingerprint model matches associated with the intended user. This mayrequire the user to place the user's fingerprint on the biometric sensor550 multiple times in order for the biometric sensor 550 to detectmultiple fingerprint models.

In some embodiments, the user may be required to keep the user's fingeron the biometric sensor 550 for the duration of the dosage dispensingcycle. In other embodiments, the user may be able to remove the user'sfinger from the biometric sensor 550 after the biometric sensor 550detects the user's fingerprint model and before the end of the dosagedispensing cycle.

In some embodiments, the processor 310 receives, from the biometricsensor 550, an input associated with the respective biometric attributesdetected by the biometric sensor 550. The received input may be anelectrical signal representative of the detected biometric attribute(s).Based on the input received by the processor 310, the processor 310 maydetermine whether the current detected biometric attribute matches astored biometric attribute of the intended user. Upon detecting amatching biometric attribute, the processor 310 may continue the dosagedispensing process, as described in greater detail herein.

FIG. 10 provides a perspective view of the COPA device 100 coupled to ahousing 500. In some embodiments, the COPA device 100 is coupled to thehousing 500 via a docking port 530. The housing 500 may include an upperportion 510 and a lower portion 520. In FIG. 10 , the micro-pump unit300 is positioned within the upper portion 510 of the housing 500. Thereservoir 320 of the micro-pump unit 300 may be connected to the COPAdevice 100 via a tubular member 540, which may be a hose structure insome embodiments. The tubular member 540 may be a flexible material, orthe tubular member 540 may be rigid. When the actuator 330 is activated,the actuator 330 delivers an exact dosage of the prescribed substance(e.g., the prescribed substance 720) from the reservoir 320 to theintended user's mouth via the tubular member 540. The tubular member 540may extend through the docking port 530, terminating at the exit port532 within the intended user's mouth, to enable the prescribed substanceto be delivered directly into the intended user's mouth for ingestion.In some embodiments, the COPA device 100 may include an access opening134 (FIGS. 1 and 7 ). The tubular member 540 may enter the docking port530 via the access opening 134 of the COPA device 100. In someembodiments, the micro-pump unit 300 may be positioned within the lowerportion 520 of the housing 500.

In some embodiments, the housing 500 is sized and shaped to allow acommercial prescription medication bottle to fit within the housing 500(e.g., medication bottle 590 in FIG. 14 ). In these embodiments, theprescription medication bottle may constitute a reservoir (e.g., thereservoir 320) for the prescribed substance (e.g., a liquid, pills,etc.). The prescribed substance (e.g., the prescribed substance 720) maybe delivered directly into the intended user's mouth via atransportation channel (e.g., tubular member 540). Similar to themicro-pump unit 300, upon activation, the actuator 330 may deliver anexact dosage of the prescribed substance to the intended user from theprescription medication bottle. The actuator 330 may be activated by theprocessor 310 in response to an indication that the COPA device 100 iswithin the intended user's mouth, the indication being determined by oneor more processes described herein. In other embodiments, an actuatorwithin the housing 500 (e.g., a different actuator than the actuator330) may deliver an exact dosage of the prescribed substance to theintended user from the prescription medication bottle.

FIG. 11 provides a perspective view of the COPA device 100 coupled tothe housing 500. In the embodiment in FIG. 11 , the micro-pump unit 300is arranged to be positioned within the compartment 114 in the COPAdevice 100. During use, the micro-pump unit 300 is positioned within theCOPA device 100. In some embodiments, the housing 500 may include athumbprint or optical scanning component (e.g., biometric sensor 550,which is discussed above with respect to FIG. 9 ) to verify that theintended user is attempting to obtain a prescribed substance (e.g., theprescribed substance 720). Upon verification of the intended user, theactuator 330 may be activated. In other embodiments, the actuator 330 isactivated by the processor 310 after the processor 310 determines, basedon an input received from the top side capacitive sensor array 716 (FIG.18 ) and/or the bottom side capacitive sensor array 718 (FIG. 19 ), thatthe COPA device 100 is within the intended user's mouth.

Similar to the discussion above with respect to FIG. 10 , in someembodiments, the housing 500 is shaped to allow a commercialprescription medication bottle (e.g., the medication bottle 590 in FIG.14 ) to fit within the housing 500. In this embodiment, the prescriptionmedication bottle may constitute a reservoir (e.g., the reservoir 320)for the prescribed substance (e.g., a liquid, pills, etc.). Theprescribed substance (e.g., the prescribed substance 720) may bedelivered directly into the intended user's mouth via a transportationchannel. Similar to the micro-pump unit 300, upon activation, theactuator 330 may deliver an exact dosage of the prescribed substance tothe intended user from the prescription medication bottle. The actuator330 may be activated by the processor 310 in response to an indicationthat the COPA device 100 is within the intended user's mouth, theindication being determined by one or more processes described herein.In other embodiments, an actuator within the housing 500 (e.g., adifferent actuator than the actuator 330) may deliver an exact dosage ofthe prescribed substance to the intended user from the prescriptionmedication bottle.

FIG. 12 provides a perspective view of the COPA device 100 including anenvironmental sensor 560 according to embodiments of the presentdisclosure. In some embodiments, the environmental sensor 560 is coupledto and/or integrated in the COPA device 100. For example, theenvironmental sensor 560 may be coupled to a wall of the COPA device100, positioned on the surface of the wall of the COPA device 100, orpositioned partially or fully within the wall of the COPA device 100. Insome embodiments, the environmental sensor 560 is coupled to the backwall portion 128 or the front wall portion 126 of the COPA device 100.In other embodiments, the environmental sensor 560 may be coupled to anouter face 129 of the back wall portion 128, or the environmental sensor560 may be positioned partially or fully within the back wall portion128. In further embodiments, the environmental sensor 560 may be coupledto an outer face 127 of the front wall portion 126, or the environmentalsensor 560 may be positioned partially or fully within the front wallportion 126.

The COPA device 100 may include one environmental sensor (e.g., theenvironmental sensor 560), or the COPA device 100 may include multipleenvironmental sensors, with one of the environmental sensors being theenvironmental sensor 560. All of the multiple environmental sensors maybe duplicates of the environmental sensor 560. The multipleenvironmental sensors can be configured to detect differentenvironmental attributes.

In some embodiments, the environmental sensor 560 may be configured todetect one or more environmental attributes such as temperature,humidity, carbon dioxide (CO₂), volatile organic compounds (VOCs),barometric pressure, the presence of saliva, and/or any other suitableenvironmental attribute. In other embodiments, the environmental sensor560 may be configured to detect DNA (e.g., saliva) of the user. In someembodiments, the processor 310 receives, from the environmental sensor560, an input associated with the respective environmental attributesdetected by the environmental sensor 560. The received input may be anelectrical signal representative of the detected environmentalattribute(s). Based on the input received by the processor 310, theprocessor 310 may determine whether the COPA device 100 is positionedwithin the user's mouth.

In an exemplary embodiment, the environmental sensor 560 may detect theambient temperature of the air surrounding the environmental sensor 560.Thus, when the COPA device 100 is placed within the user's mouth, theenvironmental sensor 560 detects the temperature of the air inside theuser's mouth. The processor 310 may then receive the temperaturevalue(s) detected by the environmental sensor 560. The processor 310 mayreceive the temperature value(s) by a wireless and/or a wiredconnection. In an exemplary embodiment, the processor 310 includes astored, pre-defined range of temperature values, which may be stored inthe memory 370 (FIG. 7 ). When the processor 310 receives a temperaturevalue from the environmental sensor 560 that is within the pre-definedrange of temperature values, the processor 310 may determine that theenvironmental sensor 560, and, therefore, the COPA device 100, ispositioned within the user's mouth. The temperature values in thepre-defined range of temperature values may include values from 97degrees Fahrenheit (° F.) to 99° F. The above range of temperatures islisted for exemplary purposes only. Temperatures of less than 97° F. andgreater than 99° F. are also contemplated by the present disclosure.

While the embodiment in FIG. 12 depicts the environmental sensor 560 asone sensor, in some embodiments, the environmental sensor 560 may bemultiple environmental sensors. For example, the COPA device 100 mayinclude a separate temperature sensor, a separate humidity sensor, aseparate CO₂ sensor, etc., and each of the above sensors may be locatedat different respective locations on the COPA device 100. For example,the temperature sensor may be located on the outer face 129 of the backwall portion 128 of the COPA device 100, and the humidity sensor may belocated on the outer face 127 of the front wall portion 126 of the COPAdevice 100. In other embodiments, the COPA device 100 may includeduplicates of the environmental sensor 560. Each of the duplicates ofthe environmental sensor 560 may be located at different respectivelocations on the COPA device 100. For example, one environmental sensor560 may be located on the outer face 129 of the back wall portion 128 ofthe COPA device 100, and another environmental sensor may be located onthe outer face 127 of the front wall portion 126 of the COPA device 100.

FIG. 13 provides a perspective view of the COPA device 100 coupled tothe housing 500 according to embodiments of the present disclosure. Insome embodiments, the COPA device 100 may be mechanically coupled andfluidly coupled to the housing 500. The COPA device 100 is mechanicallycoupled to the housing 500 via the docking port 530 (FIG. 10 ) such thatthe COPA device 100 and the housing 500 move together. The COPA device100 is fluidly coupled (or in fluid communication with) the housing 500via the tubular member 540 such that a prescribed substance (e.g., theprescribed substance 720) travels from the housing 500 to the COPAdevice 100 via the tubular member 540. In the embodiment shown in FIG.13 , the housing 500 includes the biometric sensor 550 (FIG. 9 ).Further, the COPA device 100 includes the environmental sensor 560 (FIG.12 ).

FIG. 14 provides a perspective view of an interior of the housing 500according to embodiments of the present disclosure. In the embodimentshown in FIG. 14 , the housing 500 includes a medication bottle 590, acap 592, a dip tube 594, a valve 596, a pump 598, a tubular connector580, and the tubular member 540 (see FIG. 15 ). The medication bottle590 may be the reservoir 320 (FIG. 6 ). The pump 598 may be the actuator330 (FIG. 6 ), and the valve 596 may be similar to the exit valves 340(FIG. 6 ).

The medication bottle 590 may be used to hold a prescribed substance,which may be the prescribed substance 720. In some embodiments, theprescribed substance 720 may be in liquid form. For example, theprescribed substance 720 may be a liquid form of oxycodoneHydrochloride, morphine concentrate, lorazepam, Zoloft sertraline HCL,or any other suitable substance. In some examples, the prescribedsubstance 720 may be any of the substances listed above or any substancethat has not yet been produced, created, developed, or manufactured, butmay be produced, created, developed, or manufactured in the future. Theprescribed substance 720 may be a combination of any of the substanceslisted above or a combination of the substances listed above withsubstances that have not yet been produced, created, developed, ormanufactured, or with any other suitable substance. In otherembodiments, the medication bottle 590 may include a prescribedsubstance in the form of pellets, granules, micro particles, minitablets, powders, pills, etc. The medication bottle 590 may be sized tocontain multiple doses (e.g., a day(s), week(s), month(s), etc.) of theprescribed substance based on the intended user's dosage information. Insome instances, the volume of the medication bottle 590 is equal to orgreater than 15 ml, 30 ml, 60 ml, 90 ml, 120 ml, 180 ml, 240 ml, 360 ml,480 ml, or more. The volume of the medication bottle 590 may be sizedbased on expected dosage sizes, expected substance form (e.g., liquid,pellets, granules, micro particles, mini tablets, powders, pills, etc.),and/or combinations thereof.

The pump 598 can be utilized to dispense the prescribed substance fromthe medication bottle 590, through the COPA device 100, and into theintended user's mouth via a tubular connector 580 and the tubular member540 (FIG. 10 ). In this regard, the components in the interior of thehousing 500 may be similar to the micro-pump unit 300 described above(FIGS. 6-8 ). In some instances, the tubular connector 580 may bereplaced by the tubular member 540, such that the tubular member 540extends from the COPA device 100, through the pump 598, and connects tothe valve 596. In other instances, the tubular member 540 may bereplaced by the tubular connector 580, such that the tubular connector580 extends from the valve 596, through the pump 598, and connects tothe COPA device 100.

In some embodiments, a distal end 600 of the dip tube 594 is disposedwithin the medication bottle 590 so that the distal end 600 of the diptube 594 terminates just above a base 591 of the medication bottle 590.Thus, substantially all of a length of the dip tube 594 may bepositioned within the medication bottle 590. This may allow for theprescribed substance 720 to enter the distal end 600 of the dip tube 594and flow through the dip tube 594, which may be a hollow tube. Aproximal end 602 of the dip tube 594 may be connected to a distal end604 of the valve 596. A proximal end 606 of the valve 596 may beconnected to a distal end 608 of the tubular connector 580. A proximalend 610 of the tubular connector 580 may be connected to a distal end612 of the pump 598, and a proximal end 614 of the pump 598 may beconnected to a distal end 616 of the tubular member 540. A proximal end618 of the tubular member 540 may terminate within the COPA device 100.In some embodiments, the tubular member 540 connects to the reservoir320 (FIG. 7 ) of the micro-pump unit 300, which then delivers theprescribed substance 720 into the user's mouth via the exit valves 340(FIG. 7 ). In other embodiments, the tubular member 540 extends throughthe COPA device 100 and into the docking port 530, and the prescribedsubstance 720 is delivered into the user's mouth via an exit port 532 inthe docking port 530. In various examples, the tubular member 540extends through the COPA device 100 and the docking port 530 andconnects to the exit port 532. The prescribed substance 720 is thendelivered into the user's mouth via the tubular member 540. Any one ofthe respective connections such as the connections between one or moreof the dip tube 594, the valve 596, the tubular connector 580, the pump598, the tubular member 540, the docking port 530, the exit port 532,and/or the COPA device 100 described above may be a male/femaleengagement, a snap fit, a press fit, a threaded engagement, an adhesiveconnection, a solder engagement, a fastened engagement, a weldedconnection, a brazing connection, or any other suitable coupling tofacilitate transfer of the prescribed substance 720.

In some embodiments, the tubular member 540 may be in fluidcommunication and mechanical communication, such as physically coupled,with the pump 598 and the COPA device 100, respectively. In otherembodiments, the dip tube 594 may be in fluid communication andmechanical communication, such as physically coupled, with the valve596.

FIG. 15 provides a detailed view of the housing 500 with the medicationbottle 590 positioned outside of the housing 500. In this regard, FIG.15 is a cross-sectional view of the housing 500 according to embodimentsof the present disclosure. The cross-sectional view is taken alongsection line 15-15 of FIG. 14 . In the embodiment of FIG. 15 , themedication bottle 590 is positioned outside of the housing 500, and themedication bottle 590 is filled with the prescribed substance 720. Themedication bottle 590 may only be directly handled by an authorizedperson, such as a pharmacist. The user may not directly handle themedication bottle 590 to prevent unauthorized access to the prescribedsubstance 720. In some instances, an authorized person may, afterreceiving the medication bottle 590 from a supplier, remove the originalcap of the medication bottle 590 and replace the original cap with acustom cap, such as the cap 592. The cap 592 may include the dip tube594 and the valve 596. In various examples, the cap 592 and/or themedication bottle 590 can include threads, and the medication bottle 590and/or the cap 592 can include corresponding grooves to receive thethreads. In this manner, the cap 592 and the medication bottle 590 canbe threadingly coupled.

In some embodiments, after placing the cap 592 on the medication bottle590, the authorized person may insert the medication bottle 590 into thehousing 500. To insert the medication bottle 590 into the housing 500,the authorized person may first remove the bottom wall 570 of thehousing 500. Then, the authorized person may insert the medicationbottle 590 into the lower portion 520 of the housing 500. Afterinserting the medication bottle 590 into the lower portion 520, theauthorized person may replace the bottom wall 570 and lock the bottomwall 570 in place with a locking mechanism to securely seal the bottomwall 570 onto the housing 500 in a manner that prevents unauthorizedaccess to the medication bottle 590. In some embodiments, the lockingmechanism may be a key lock, a magnetic lock, an electronic lock, amechanical lock, a quick connect lock, or any other suitable lockingmechanism. In some embodiments, the locking mechanism may securely sealthe bottom wall 570 to the front wall 524 when the front wall 524 iscoupled to the bottom wall 570.

FIG. 16 provides a detailed view of the housing 500 with the medicationbottle 590 positioned inside of the housing 500. In this regard, FIG. 16is a cross-sectional view of the housing 500 according to embodiments ofthe present disclosure. The cross-sectional view is taken along sectionline 15-15 of FIG. 14 . In the embodiment of FIG. 16 , the medicationbottle 590 is positioned within the housing 500, and the medicationbottle 590 is filled with the prescribed substance 720. In someembodiments, the pump 598 can be utilized to dispense the prescribedsubstance 720 from the medication bottle 590 into the intended user'smouth after the processor 310 determines that the intended user'sfingerprint has been scanned by the biometric sensor 550 (FIG. 9 ),after the processor 310 determines that the COPA device 100 is withinthe intended user's mouth (as discussed above with respect to FIG. 12 ),and/or after the processor 310 determines that the intended user's mouthis within the recess of the COPA device 100 (which will be discussed ingreater detail herein with respect to FIGS. 18-25B). In some instances,the prescribed substance 720 travels from the medication bottle 590 tothe intended user's mouth via the dip tube 594, the valve 596, thetubular connector 580, the pump 598, the tubular member 540, the dockingport 530, and the exit port 532.

In some embodiments, after a dosage has been delivered to the intendeduser, the valve 596 may purge the tubular connector 580, the pump 598,and the tubular member 540 with air. For example, the valve 596 mayinject air into the tubular connector 580, the pump 598, and the tubularmember 540. The injection of air may ensure that any remaining residuefrom the dosage of the prescribed substance 720 is removed from thetubular connector 580, the pump 598, and the tubular member 540. In someinstances, the valve 596 may be a purge valve, a canister purge valve, acheck valve, a pinch valve, a diaphragm valve, a solenoid valve, a ballvalve, or any other suitable valve. In some embodiments, the pump 598may continue to provide dosages, one at a time, of the prescribedsubstance 720 to the intended user according to a dosage time tableand/or a dosage schedule. Doses may continue to be delivered for theprescribed period of time, for the prescribed number of doses, and/oruntil the amount of the prescribed substance 720 in the medicationbottle 590 is depleted.

FIG. 17 provides a detailed view of the housing 500 with an emptymedication bottle 590 positioned outside of the housing 500. In thisregard, FIG. 17 is a cross-sectional view of the housing 500 accordingto embodiments of the present disclosure. The cross-sectional view istaken along section line 15-15 of FIG. 14 . In the embodiment of FIG. 17, the medication bottle 590 is positioned outside of the housing 500,and the medication bottle 590 is empty (i.e., all of the prescribedsubstance 720 is removed from the medication bottle 590). In someinstances, after the medication bottle 590 is empty, the user may bringthe housing 500 to an authorized person, such as a pharmacist. When theauthorized person receives the housing 500 from the user, the authorizedperson may remove the bottom wall 570 from the housing 500. To removethe bottom wall 570, the authorized person may unlock the bottom wall570 from the housing 500. Then, the authorized person may remove theempty medication bottle 590 from the housing 500. In some embodiments,the authorized person may refill the medication bottle 590 with theprescribed substance 720 and place the medication bottle 590 back intothe housing 500. After placing the medication bottle 590 within thehousing 500, the authorized person may lock the bottom wall 570 onto thehousing 500.

In other embodiments, after the authorized person removes the emptymedication bottle 590 from the housing 500, the authorized person maynot need to refill the medication bottle 590 with the prescribedsubstance 720. For example, the authorized person may not need to refillthe medication bottle 590 when the user's dosage schedule is complete.If the user's dosage schedule is complete, then the authorized personmay keep the housing 500 with the attached COPA device 100 to besterilized and then used for a subsequent user. In some embodiments, theauthorized user may remove the medication bottle 590 from the housing500 while the medication bottle is partially full of the prescribedsubstance 720. For example, the medication bottle 590 may be partiallyfull even after after the prescribed period of time has passed and/orafter the prescribed number of doses have been administered.

While it has been discussed above with respect to FIGS. 15-17 that anauthorized person may unlock and remove the bottom wall 570 of thehousing 500 in order to access the medication bottle 590, it isunderstood that any other wall of the housing 500 may be removed inorder to access the medication bottle 590. For example, the authorizedperson may unlock and remove a back wall or a side wall of the housing500 to access the medication bottle 590.

FIG. 18 provides a detailed view of the top side 102 of the COPA device100 according to embodiments of the present disclosure. In this regard,FIG. 18 is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong section line 18-18 of FIG. 1 . The top side 102 includes a topside outer layer 712, a top side intermediate layer 706, and a baselayer 702. The top side outer layer 712 is adjacent to the top sideintermediate layer 706, and the top side intermediate layer 706 isadjacent to the base layer 702. The top side outer layer 712 may besubstantially planar. This may allow the COPA device 100 to fit within aplurality of different mouths with a plurality of different dentitions.

In some embodiments, the top side intermediate layer 706 may bepositioned under and in contact with the top side outer layer 712. Thetop side intermediate layer 706 may be directly in contact with the topside outer layer 712. For example, a top surface of the top sideintermediate layer 706 may be in contact with a bottom surface of thetop side outer layer 712. In some embodiments, the top side intermediatelayer 706 may be connected to the top side outer layer 712.

In some embodiments, the base layer 702 may be positioned under and incontact with the top side intermediate layer 706. The base layer 702 maybe directly in contact with the top side intermediate layer 706. Forexample, a top surface of the base layer 702 may be in contact with abottom surface of the top side intermediate layer 706. In someembodiments, the base layer 702 may be connected to the top sideintermediate layer 706.

Additionally, a top side capacitive sensor array 716 may be embeddedwithin the base layer 702. The top side capacitive sensor array 716 maybe positioned within the base layer 702 to be adjacent to the top sideintermediate layer 706 (e.g., adjacent to a bottom surface of the topside intermediate layer 706). In some embodiments, the top sidecapacitive sensor array 716 may be composed of a plurality ofcapacitance sensors. The plurality of capacitance sensors may bearranged in a straight line. In other embodiments, the plurality ofcapacitance sensors may be arranged in several rows of straight lines.In some embodiments, the plurality of capacitance sensors may bearranged in any other suitable pattern including curved patterns and/ornon-linear patterns.

In some embodiments, both the top side outer layer 712 and the top sideintermediate layer 706 are made of a biocompatible impression materialor polymer. The base layer 702 may be made of a biocompatible impressionmaterial or polymer, or the base layer 702 may be made of a more rigidmaterial. For example, the base layer 702 may be made of closed cellfoam, nonconductive gel, rubber, paper, polyester, polystyrene,polypropylene, plastic, porcelain, Teflon, ceramic, fiberglass, or anyother suitable material. The top side outer layer 712 and the top sideintermediate layer 706 may be deformable so that the layers deform whena user bites down on the COPA device 100.

The plurality of capacitance sensors in the top side capacitive sensorarray 716 may be any suitable type of capacitance sensors. For example,the plurality of capacitance sensors may be object detection sensors,level detection sensors, capacitive displacement sensors, capacitiveproximity sensors, mutual capacitance sensors, self-capacitance sensors,and any other suitable capacitance sensors. A capacitor is a device thatconsists of two electrodes separated by an insulator (e.g., adielectric). In some examples, the dielectric may be air, mica, Mylar,rubber, paper, polyester, polystyrene, polypropylene, plastic,porcelain, Teflon, ceramic, solder mask, fiberglass, glass, or any othersuitable insulating material (e.g., a gas, liquid, or solid material).In some embodiments, the capacitance sensors may be integratedcapacitors. In some examples, the integrated capacitors may take theform of plates/planar electrodes, rods, tubes, purchased sensors,modified sensors, custom sensors, or any combination of materials thatresults in the generation of an electric field that can be interactedwith to modify the materials' capacitance. In some embodiments, thecapacitance sensors in the top side capacitive sensor array 716 detectdentition positioning, arrangement, shape, and any other suitabledentition-related measurement.

The top side outer layer 712 may be made of a capacitive material (e.g.,any suitable material containing at least one layer of electricallyconductive material or any material that is impregnated and/or metalizedwith conductive material, such as anti-static conductive foam, forexample). In some examples, the top side intermediate layer 706 may bemade of a nonconductive material that will deform under pressure andthen recover. For example, the top side intermediate layer 706 may bemade of rubber, nonconductive gel, closed cell foam, or any othersuitable material. In some embodiments, the top side outer layer 712 maybe removably coupled to the top side intermediate layer 706. Forexample, in some embodiments, the top side outer layer 712 may beremoved from the top side 102. The top side outer layer 712 may beremoved when the user has a sufficient number of structural features(e.g., prosthetics, such as crowns, bridges, metallic fillings, etc.) onthe user's teeth that a sufficient capacitive map of the user'sdentition will be detected by the top side capacitive sensor array 716.

FIG. 19 provides a detailed view of the top side 102 and the bottom side104 of the COPA device 100 according to embodiments of the presentdisclosure. In this regard, FIG. 19 is a cross-sectional view of theCOPA device 100 according to embodiments of the present disclosure. Thecross-sectional view is taken along section line 18-18 of FIG. 1 . Asdiscussed above with respect to FIG. 1 , the bottom side 104 includes abottom side outer layer 714 and a bottom side intermediate layer 708.The bottom side outer layer 714 is adjacent to the bottom sideintermediate layer 708, and the bottom side intermediate layer 708 isadjacent to the base layer 702. The bottom side outer layer 714 may besubstantially planar. This may allow the COPA device 100 to fit within aplurality of different mouths with a plurality of different dentitions.

In some embodiments, the bottom side intermediate layer 708 may bepositioned under and in contact with the bottom side outer layer 714.The bottom side intermediate layer 708 may be directly in contact withthe bottom side outer layer 714. For example, a top surface of thebottom side intermediate layer 708 may be in contact with a bottomsurface of the bottom side outer layer 714. In some embodiments, thebottom side intermediate layer 708 may be connected to the bottom sideouter layer 714.

In some embodiments, the base layer 702 may be positioned under and incontact with the bottom side intermediate layer 708. The base layer 702may be directly in contact with the bottom side intermediate layer 708.For example, a bottom surface of the base layer 702 may be in contactwith a bottom surface of the bottom side intermediate layer 708. In someembodiments, the base layer 702 may be connected to the bottom sideintermediate layer 708.

Additionally, a bottom side capacitive sensor array 718 may be embeddedwithin the base layer 702. The bottom side capacitive sensor array 718may be positioned within the base layer 702 to be adjacent to the bottomside intermediate layer 708 (e.g., adjacent to a bottom surface of thebottom side intermediate layer 708). As shown in FIG. 19 , both the topside capacitive sensor array 716 and the bottom side capacitive sensorarray 718 may each be embedded within the base layer 702. In someembodiments, the bottom side capacitive sensor array 718 may be composedof a plurality of capacitance sensors. The plurality of capacitancesensors may be arranged in a straight line. In other embodiments, theplurality of capacitance sensors may be arranged in several rows ofstraight lines. In some embodiments, the plurality of capacitancesensors may be arranged in any other suitable pattern including curvedpatterns and/or non-linear patterns.

In some embodiments, both the bottom side outer layer 714 and the bottomside intermediate layer 708 are made of a biocompatible impressionmaterial or polymer. For example, the base layer 702 may be made ofclosed cell foam, nonconductive gel, rubber, paper, polyester,polystyrene, polypropylene, plastic, porcelain, Teflon, ceramic,fiberglass, or any other suitable material. The bottom side outer layer714 and the bottom side intermediate layer 708 may be deformable so thatthe layers deform when a user bites down on the COPA device 100.

The plurality of capacitance sensors in the bottom side capacitivesensor array 718 may be any suitable type of capacitance sensors. Forexample, the plurality of capacitance sensors may be object detectionsensors, level detection sensors, capacitive displacement sensors,capacitive proximity sensors, mutual capacitance sensors,self-capacitance sensors, and any other suitable capacitance sensors. Asdiscussed above with respect to FIG. 18 , a capacitor is a device thatconsists of two electrodes separated by an insulator (e.g., adielectric). In some examples, the dielectric may be air, mica, Mylar,rubber, paper, polyester, polystyrene, polypropylene, plastic,porcelain, Teflon, ceramic, solder mask, fiberglass, glass, or any othersuitable insulating material (e.g., a gas, liquid, or solid material).In some embodiments, the capacitance sensors may be integratedcapacitors. In some examples, the integrated capacitors may take theform of plates/planar electrodes, rods, tubes, purchased sensors,modified sensors, custom sensors, or any combination of materials thatresults in the generation of an electric field that can be interactedwith to modify the materials' capacitance. In some embodiments, thecapacitance sensors in the bottom side capacitive sensor array 718detect dentition positioning, arrangement, shape, and any other suitabledentition-related measurement.

The bottom side outer layer 714 may be made of a capacitive material(e.g., any suitable material containing at least one layer ofelectrically conductive material or any material that is impregnatedand/or metalized with conductive material, such as anti-staticconductive foam, for example). In some examples, the bottom sideintermediate layer 708 may be made of a nonconductive material that willdeform under pressure and then recover. For example, the bottom sideintermediate layer 708 may be made of rubber, nonconductive gel, closedcell foam, or any other suitable material. In some embodiments, thebottom side outer layer 714 may be removably coupled to the bottom sideintermediate layer 708. For example, in some embodiments, the bottomside outer layer 714 may be removed from the bottom side 104. The bottomside outer layer 714 may be removed when the user has a sufficientnumber of structural features (e.g., prosthetics, such as crowns,bridges, metallic fillings, etc.) on the user's teeth that a sufficientcapacitive map of the user's dentition will be detected by the bottomside capacitive sensor array 718.

FIG. 20 provides a detailed view of the bottom side 104 of the COPAdevice 100 according to embodiments of the present disclosure. In thisregard, FIG. 20 is a cross-sectional view of the COPA device 100according to embodiments of the present disclosure. The cross-sectionalview is taken along section line 18-18 of FIG. 1 . In some embodiments,the COPA device includes a capacitive sensor array only on the top side102 (FIG. 18 ). In other embodiments, the COPA device includes acapacitive sensor array only on the bottom side 104 (FIG. 20 ). In stillother embodiments, the COPA device includes a capacitive sensor array onboth the top side 102 and the bottom side 104 (FIGS. 19, 21, 24 ).

FIG. 21 provides a detailed view of the top side 102 and the bottom side104 of the COPA device 100 according to embodiments of the presentdisclosure. In this regard, FIG. 21 is a cross-sectional view of theCOPA device 100 according to embodiments of the present disclosure. Thecross-sectional view is taken along section line 18-18 of FIG. 1 . Inthe embodiment shown in FIG. 21 , the top side 102 includes the top sideouter layer 712 and the top side intermediate layer 706. Compared toFIG. 19 , the embodiment of FIG. 21 omits the bottom side capacitivesensor array 718 and the bottom side outer layer 714. The base layer 702includes only the top side capacitive sensor array 716, and the bottomside 104 includes only the bottom side intermediate layer 708. Theembodiment shown in FIG. 21 may result in lower manufacturing costs formanufacturing the COPA device 100 because the COPA device 100 in FIG. 21includes fewer layers than, for example, the COPA device 100 in FIG. 19. Additionally, the COPA device 100 shown in FIG. 21 may provide morecomfort to the user due to there being fewer layers.

FIG. 22 provides a detailed view of the top side 102 of the COPA device100 according to embodiments of the present disclosure. In this regard,FIG. 22 is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong section line 18-18 of FIG. 1 . Compared to FIG. 18 , theembodiment of FIG. 22 omits the top side outer layer 712. In theembodiment shown in FIG. 22 , the top side 102 includes only the topside intermediate layer 706 and the base layer 702 (which includes thetop side capacitive sensor array 716). The embodiment shown in FIG. 22may result in lower manufacturing costs for manufacturing the COPAdevice 100 because the COPA device 100 in FIG. 22 includes fewer layersthan, for example, the COPA device 100 in FIG. 18 . Additionally, theCOPA device 100 shown in FIG. 22 may provide more comfort to the userdue to there being fewer layers.

The COPA device 100 can be formed of any combination of layers andcapacitive sensor arrays as discussed above according to embodiments ofthe present disclosure. The COPA device 100 can also be formed of anycombination of layers and capacitive sensor arrays that may not havebeen discussed above but would be a suitable combination.

FIG. 23 provides a detailed view of the top side 102 of the COPA device100 according to embodiments of the present disclosure. In this regard,FIG. 23 is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong section line 18-18 of FIG. 1 . In the embodiment shown in FIG. 22, the top side 102 is depicted in a state of deformation. Thedeformation of the top side 102 is caused by a plurality of upper teeth722 of the user. When the user bites down on the top side 102, the topside outer layer 712 and the top side intermediate layer 706 may deformdue to pressure applied by the plurality of upper teeth 722 on the topside outer layer 712. In some embodiments, the top side capacitivesensor array 716 generates a signal/input (e.g., a capacitive map) basedon the deformation. The processor 310 may then receive the signal/input.

FIG. 24 provides a detailed view of the top side 102 and the bottom side104 of the COPA device 100 according to embodiments of the presentdisclosure. In this regard, FIG. 24 is a cross-sectional view of theCOPA device 100 according to embodiments of the present disclosure. Thecross-sectional view is taken along section line 18-18 of FIG. 1 .

In the embodiment shown in FIG. 24 , the top side 102 and the bottomside 104 are each depicted in a state of deformation. The deformation ofthe top side 102 is caused by a plurality of upper teeth 722 of theuser, and the deformation of the bottom side 104 is caused by aplurality of lower teeth 724 of the user. When the user bites down onthe top side 102, the top side outer layer 712 and the top sideintermediate layer 706 may deform due to pressure applied by theplurality of upper teeth 722 on the top side outer layer 712. When theuser bites on the bottom side 104, the bottom side outer layer 714 andthe bottom side intermediate layer 708 may deform due to pressureapplied by the plurality of lower teeth 724 on the bottom side outerlayer 714.

In some embodiments, the base layer 702 may not deform or may onlydeform a marginal amount. The base layer 702 may not deform to ensurethe top side capacitive sensor array 716 and/or the bottom sidecapacitive sensor array 718 accurately detects any changes incapacitance. The top side capacitive sensor array 716 may detect changesin capacitance based on deformation of the top side intermediate layer706 and/or the top side outer layer 712. The deformation may be causedby the user biting down on the top side 102 of the COPA device 100. Thedetected changes in capacitance may be in the form of a capacitive map,which includes capacitance readings for all or substantially all of theuser's upper teeth (e.g., the plurality of upper teeth 722). The topside capacitance sensor array 716 may detect multiple capacitive mapsbased on multiple inputs (e.g., deformation of the top side intermediatelayer 706 and/or the top side outer layer 712) in order to define arange of acceptable capacitive map matches associated with the intendeduser. This may require the user to bite down on the top side 102 of theCOPA device 100 multiple times in order for the top side capacitivesensor array 716 to generate multiple capacitive maps.

The bottom side capacitive sensor array 718 may detect changes incapacitance based on deformation of the bottom side intermediate layer708 and/or the bottom side outer layer 714. The deformation may becaused by the user biting on the bottom side 104 of the COPA device 100.The detected changes in capacitance may be in the form of a capacitivemap, which includes capacitance readings for all or substantially all ofthe user's lower teeth (e.g., the plurality of lower teeth 724). Thebottom side capacitance sensor array 718 may detect multiple capacitivemaps based on multiple inputs (e.g., deformation of the bottom sideintermediate layer 708 and/or the bottom side outer layer 714) in orderto define a range of acceptable capacitive map matches associated withthe intended user. This may require the user to bite on the bottom side104 of the COPA device 100 multiple times in order for the bottom sidecapacitive sensor array 718 to generate multiple capacitive maps.

FIG. 25A provides a detailed view of the top side 102 of the COPA device100 according to embodiments of the present disclosure. In this regard,FIG. 25A is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong section line 18-18 of FIG. 1 . In the embodiment shown in FIG.25A, the top side 102 is depicted in a state of deformation. Thedeformation of the top side 102 is caused by a plurality of upper teeth722 of the user (see FIG. 24 ). FIG. 25A illustrates an upper tooth 726(which may be part of the plurality of upper teeth 722), which iscausing deformation of a portion of the top side 102 according toembodiments of the present disclosure. An amount of deformation in FIG.25A is illustrated by distance A, which is a distance between a topsurface of the top side capacitive sensor array 716 and a bottom surfaceof the top side outer layer 712.

In the embodiment shown in FIG. 25A, the top side 102 includes the topside outer layer 712. As discussed previously, the top side outer layer712 may be made of a capacitive material. Therefore, when the top sideouter layer 712 is deformed (e.g., when the user bites down on the topside 102), the processor 310 receives an input from the top sidecapacitive sensor array 716 based on the deformation. The top side outerlayer 712 is included in the top side 102 in this embodiment because theupper tooth 726 does not have any capacitive structural features (e.g.,prosthetics, such as a crown, a bridge, a metallic filling, etc.).Having the top side outer layer 712 allows for capacitance to bedetected by the processor 310 even if the upper tooth 726 and/or topside intermediate layer 706 do not themselves have enough capacitance.When the top side outer layer 712 is included, the processor 310 willreceive an input from the top side capacitive sensor array 716 based ondeformation of the top side outer layer 712.

FIG. 25B provides a detailed view of the top side 102 of the COPA device100 according to embodiments of the present disclosure. In this regard,FIG. 25B is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong section line 18-18 of FIG. 1 . In the embodiment shown in FIG.25B, the top side 102 is depicted in a state of deformation. Thedeformation of the top side 102 is caused by a plurality of upper teeth722 of the user (see FIG. 24 ). FIG. 25B illustrates an upper tooth 726(which may be part of the plurality of upper teeth 722), which iscausing deformation of a portion of the top side 102 according toembodiments of the present disclosure. An amount of deformation in FIG.25B is illustrated by distance B, which is a distance between a topsurface of the top side capacitive sensor array 716 and a top surface ofthe top side intermediate layer 706.

Compared to FIG. 25A, the embodiment of FIG. 25B omits the top sideouter layer 712. Thus, in the embodiment shown in FIG. 25B, the top side102 includes only the top side intermediate layer 706 and the base layer702 (which includes the top side capacitive sensor array 716). In thisembodiment, though, the upper tooth 726 includes a structural feature728 that is made of a capacitive material. The structural feature 728may be a prosthetic, such as a crown, a bridge, a metallic filling, orany other dental prosthetic that is made of a capacitive material. Thestructural feature 728 provides enough capacitance to trigger the topside capacitive sensor array 716 when the user bites down on the topside 102. In some embodiments, if several of the user's teeth havestructural features (e.g., structural features similar to the structuralfeature 728), then a capacitive map that is sufficient to identify theuser may be detected by the top side capacitive sensor array 716. If thecapacitive map detected from the structural features of the user's teethis sufficient to identify the user, then the top side outer layer 712may be removed from the top side 102 (as shown in FIG. 25B). Theprocessor 310 may determine whether the capacitive map detected fromstructural features of the user's teeth is sufficient to identify theuser. For example, if the processor does not receive an input from thetop side capacitive sensor array 716, then the processor may determinethat the capacitive map, if any, detected by the top side capacitivesensor array 716 is insufficient to identify the user.

In operation, a user may place the user's finger on the biometric sensor550 on the housing 500. The biometric sensor 550 may detect afingerprint model, and the processor 310 may record and store thefingerprint model in the memory 370 in the COPA device 100. Theprocessor 310 may determine whether the scanned fingerprint model of thecurrent user matches the stored fingerprint model of the intended user.Then, the COPA device 100 may be inserted into the mouth of the userwhile the user is holding the housing 500. The environmental sensor maydetect a difference between the environmental attributes inside theuser's mouth and the environmental attributes outside the user's mouth.For example, the environmental sensor 560 may detect a highertemperature within the user's mouth than outside of the user's mouth.The processor 310 may determine whether the COPA device 100 ispositioned inside the user's mouth based on the detected environmentalattributes inside the user's mouth. The user may then close the user'smouth around the COPA device 100 and bite into the COPA device 100,which may trigger the top side capacitive sensor array 716 and/or thebottom side capacitive sensor array 718 to perform capacitancemeasurements. The processor 310 may determine whether the COPA device100 is correctly positioned within the user's mouth based on thecapacitive map detected by the top side capacitive sensor array 716and/or the bottom side capacitive sensor array 718. In some embodiments,a capacitive map of the user's mouth may be recorded and stored in thememory 370 when the COPA device 100 is created. The processor 310 maycompare the current capacitive map to the original capacitive map todetermine whether there is a match between the current user of the COPAdevice 100 and the intended user of the COPA device 100. The processor310 may also compare the current capacitive map to the originalcapacitive map to determine whether the COPA device 100 is correctlypositioned within the intended user's mouth. The processor 310 mayverify the intended user by either of, or both of, the COPA device 100(specifically, the top side and/or bottom side capacitive sensor arrays716, 718) and the housing 500 (specifically, the biometric sensor 550).Additionally, the prescribed substance 720 may be dispensed to theintended user after verification of any one, two, or three of: (1) thescanned fingerprint model of the current user matches the storedfingerprint model of the intended user; (2) the COPA device 100 ispositioned inside the user's mouth; and/or (3) the detected capacitivemap of the current user matches the stored capacitive map of theintended user.

When the user is verified as the intended user and the COPA device 100is correctly positioned within the intended user's mouth, the processor310 may send an activation instruction to the actuator 330 and open theexit valves 340 to administer one or more of the prescribed substances720 stored in the micro-pump unit 300 in accordance with dosageinstructions for the intended user. The activation of the actuator 330and the opening of the exit valves 340 may be based on dosageinstructions or prescriptions stored in the memory 370 when theprescribed substance 720 is filled.

In some embodiments, the COPA device 100 may include one or moreindicators that can provide feedback and/or alerts to the user when theCOPA device 100 is in use. The indicator(s) may include a vibratingcomponent, a sound generation component (e.g., a speaker), and/or avisual indicator component. For example, the vibrating component cancause the COPA device 100 to vibrate with different pulsing patterns toindicate the different statuses of the COPA device (e.g., one vibrationto indicate proper user authentication and initiation of dispensing, twovibrations to indicate completion of dispensing, patterned or repeatedvibrations to indicate an error with the COPA device, etc.). Similarly,the sound generation component can generate various tones and/orpatterns to indicate the different statuses of the COPA device.Likewise, the visual indicator component can include one or more LEDsthat display different colors and/or patterns to indicate the differentstatuses of the COPA device. The current status of the COPA device 100may be determined based on feedback from the processor 310, thebiometric sensor 550, the environmental sensor 560, the top sidecapacitive sensor array 716, and/or the bottom side capacitive sensorarray 718 (e.g., correct or incorrect positioning of the COPA device100), sensors for monitoring the dispensing of the substance (e.g.,volume and/or flow sensors), the docking station 400, and/or othersensors or monitoring devices associated with the COPA device 100 and/orthe docking station 400 for determining the status of the COPA device100.

FIG. 26 is a schematic diagram of a system 900 according to embodimentsof the present disclosure. The system 900 includes the COPA device 100,the docking station 400, a doctor 910, a pharmacy 920, apatient/authorized caregiver portal 930, and a central management system950 in communication with each other via a network 940. In someembodiments, the system 900 may also include the housing 500 in lieu ofor in addition to the docking station 400. The housing 500, the doctor910, the pharmacy 920, the patient/authorized caregiver portal 930, andthe central management system 950 may be in communication with eachother via the network 940. In some embodiments, the housing 500 caninclude network communication components, such as a wirelesstransceiver, a network interface device, and/or any other suitablecommunication components. In other embodiments, the housing 500 need notinclude such network communication components. The network 940 mayinclude one or more wireless access networks and/or one or more wirelinenetworks that may connect to a backbone network or the Internet. Thenetwork 940 may include network encryption and security policies forprotecting patients' privacy. The network 940 may include cloud storagefor data storage and retrieval across the network 940 based on theencryption and security policies. The doctor 910 may be a registereddoctor for the prescription management system. The pharmacy 920 may bean approved pharmacy and/or a COPA device (e.g., the mouthpiece)fabricator. A COPA fabricator may be individuals or organizationstrained in procuring standardized dental impressions (e.g., the COPAdevice 100) that capture varying individual elements of the intendedrecipients' dentition. The system 900 may provide an identificationsystem for tracking the path of prescription administration andmanagement to prevent misuse and mismanagement.

At a high level, the doctor 910 may prescribe a medication to a patientand the pharmacy 920 may create the mouthpiece for the patient and fillthe mouthpiece according to the prescription(s) provided by the doctor910. The pharmacy 920 may program the micro-pump unit of the mouthpieceto deliver an exact dosage of the prescribed medication and/or a dosageintake time. In this regard, dosage instructions for the patient may bestored in memory of the micro-pump unit. The patient may insert themouthpiece into the patient's mouth and the micro-pump unit will, uponverification that the user is the intended recipient, dispense theprescribed medication as programmed. The patient may dock the mouthpieceat the docking station when the mouthpiece is not in use. The dockingstation may charge the mouthpiece and/or communicate with the doctor 910and/or the pharmacy 920 via wireless and/or wired connections. Thedoctor 910 and/or the pharmacy 920 may monitor and retrieve informationassociated with the dispensing of the prescribed medication from thedocking station 400. The doctor 910 may provide instructions to adjustthe dosage instructions based on the monitoring and/or the retrievalinformation, and/or based on evaluations of the patient's progress. Thepharmacy 920 may send instructions to the docking station 400 to adjustthe dosage instructions stored in the memory of the micro-pump unitbased on the order from the doctor 910. For example, when the mouthpieceis docked at the docking station, the dosage instructions stored in thememory can be updated or re-programmed accordingly. Alternatively, thedosage instructions stored in the memory can be updated or re-programmedat the pharmacy 920. Similarly, the doctor 910 may prescribe newmedication based on the monitoring and/or the retrieval information,and/or based on evaluations of the patient's progress. The pharmacy 920may refill the micro-pump unit 300 accordingly. In some embodiments, thedoctor 910 and/or the pharmacy 920 may monitor and retrieve informationassociated with the dispensing of the prescribed substance from thehousing 500. The pharmacy 920 may refill the housing 500 with amedication bottle filled with a prescribed substance based on themonitoring and/or the retrieval information, and/or based on evaluationsof the patient's progress.

The patient/authorized caregiver portal 930 may be stored on a computerserver or in cloud storage on the network 940. The management system 950may be hosted on the network 940. The management system 950 may includea master database that stores information associated with the patientand all COPA activities. For example, the management system 950 mayallow doctors (e.g., the doctor 910), assembly or fulfillmenttechnicians, pharmacists (e.g., the pharmacy 920), and any healthcarepersonnel that partake in the COPA process to access at least someportions of the master database, for example, based on logins. In anembodiment, different personnel may have different login profiles andthe accesses to the master database may be based on login profiles. Insome embodiments, the patient/authorized caregiver portal 930 may behosted on the management system 950 and may have certain accesses to themaster database. The patient information may include an identificationof the patient, health history, prescription history, identification ofthe processor 310 within the COPA device 100, identification of thedocking station 400 at which the COPA device 100 is charged, etc. Thepatient's identification may include a social security number (SSN) ofthe patient or other unique identifier. The prescription history mayinclude identifications of doctors (e.g., the doctor 910) who prescribedmedications to the patient, identifications of pharmacies (e.g., thepharmacy 920) at which the prescribed medications were filled orrefilled, identifications of the prescribed medications, and anidentification of the processor 310 within the micro-pump unit 300 wherethe medications were filled. The prescription history may also be storedand managed by the management system 950. The physicians'identifications may include national provider identifiers (NPIs) of thephysicians. The NPIs are unique identification numbers for HealthInsurance Portability and Accountability Act (HIPPA) covered physicians.The pharmacies' identifications may include an impression technicianidentifier (ID), an assembly technician ID, and a registered pharmacyID. The impression technician ID identifies the technician who createdthe COPA device 100 for the patient. The assembly technician IDidentifies the technician who assembled or filled the prescribedmedication into the micro-pump unit 300 of the COPA device 100. Thepharmacy ID identifies the pharmacy at which the prescribed medicationwas filled. The prescribed medications' identifications may includedosage IDs that identify each prescribed substance or formulation filledinto the micro-pump unit 300 of the COPA device 100.

In an embodiment, the doctor 910 may examine a patient and determinewhether alternative therapies may be helpful to the patient. When thedoctor 910 determines that the patient is in need of a particularmedication, for example, according to guidelines for drug formulationsbased on COPA dosing options, the doctor may order a prescription forthe patient. The doctor 910 may electronically transmit the prescriptionto the pharmacy 920 via the network 940, for example, according to HIPPAstandards of protection for data and electronic medical record (EMR)formats.

At a COPA fabricator, a technician may create a mold for the COPA device100, for example, according to COPA guidelines and instructions. Themold may include a sealed sleeve similar to the sealed sleeve 124. Forexample, the technician may use a dental tray filled with bio friendlypolymers to create the mold. COPA approved dentists, hygienists, and/orother trained professionals (e.g., a COPA device assembly technician)may complete the creation of the mold for the COPA device 100.

An assembly technician may prepare a pre-packaged micro-pump unit 300.Each micro-pump unit 300 may be identified based on an ID of theprocessor 310 embedded within the micro-pump unit 300. The assemblytechnician may record the ID of the micro-pump unit 300 in themanagement system 950. For example, the assembly technician may enterthe ID into the management system 950, query a COPA device ID databaseof the management system 950 that stores and tracks IDs of COPA devices(e.g., the COPA device 100), and create a new record for the COPA device100 created for the patient. The assembly technician may activate theprocessor 310 within the micro-pump unit 300, for example, wirelessly.The activation may include programming the processor 310 according tothe order received from the doctor 910. The programming may include thedosage instructions for the patient (e.g., a dosage amount and thedosage timing for each prescribed medication). As described above,different chambers 322 may be filled with different formulations. Thus,the programming may include a release sequence, specific release times,and/or release durations for the different formulations, and/orintervals between releases. For example, some formulations may beprogrammed for instant release (IR) and some formulations may beprogrammed for extended release (ER).

After activating the micro-pump unit 300 or the processor 310, theassembly technician may place the activated micro-pump unit 300 into thetop center of the mold where the sealed sleeve is positioned. Themicro-pump unit 300 may be positioned such that the access cannulas 730extend outside the sealed sleeve through the access ports 122 and theexit cannulas 740 extend through the base of the mold. The assemblytechnician may place a top side capacitive sensor array 716 into thebase layer 702 of the COPA device 100. The assembly technician may alsoplace an environmental sensor 560 onto the outer face 129 of the backwall portion 128 of the COPA device 100. The assembly technician mayattach a hose from an air compressor to the access ports 122 on top ofthe mold such that pressurized air may be pumped through the accesscannulas 730 into the micro-pump unit 300 to ensure that the flowchannels 350 are not compressed during the filling of the mold. Theassembly technician may pump a liquid polymer into the mold and allowthe liquid polymer to set. After the liquid polymer is set, the COPAdevice 100 is complete.

Upon completion of the COPA device 100, the COPA device 100 can betransferred to the pharmacy 920. At the pharmacy 920, a pharmacy staff(e.g., a COPA fulfillment technician) may place the COPA device 100 on apedestal or other structure configured to allow access to the micro-pumpunit 300 for filling. The pedestal may be covered by a sterile sleeveeach time prior to placing a COPA device on the pedestal. The pharmacystaff may retrieve a record of the COPA device 100 based on the ID ofthe processor 310 within the COPA device 100, for example, from the COPAmanagement system 950 via the network 940. The pharmacy staff mayprocure the medications (e.g., vials, pouches, bottles, etc.) from adrug manufacturer based on the dosage specified in the order receivedfrom the doctor 910. The pharmacy staff may update the record for theCOPA device 100. The pharmacy staff may activate or open control valvesat the access ports 122 to inject or deposit the formulated prescription(e.g., the prescribed substance 720) into one or more chambers 322 ofthe reservoir 320 via the access ports 122. After completing thefilling, the pharmacy staff may close the control valves. The pharmacystaff may repeat the same process for filling other chambers 322 in thereservoir 320. Subsequently, the releasing of the formulatedprescription is based on matching of the intended recipient's teeth andthe COPA device 100 as described above. It should be noted that in someembodiments, the pharmacy 920 and the COPA fabricator may be the sameentity.

In other embodiments, at the pharmacy 920, a pharmacy staff (e.g., aCOPA fulfillment technician) may place the COPA device 100 on thehousing 500 to allow access to the medication bottle 590 for filling.The pharmacy staff may retrieve a record of the COPA device 100 based onthe ID of the processor 310 within the COPA device 100, for example,from the COPA management system 950 via the network 940. The pharmacystaff may procure the medications (e.g., vials, pouches, bottles, etc.)from a drug manufacturer based on the dosage specified in the orderreceived from the doctor 910. The pharmacy staff may update the recordfor the COPA device 100. The pharmacy staff may open one or more walls(e.g., the bottom wall 570) of the housing 500 to insert a medicationbottle 590 containing the formulated prescription (e.g., the prescribedsubstance 720). After completing the insertion, the pharmacy staff mayreattach the removed wall(s) of the housing. Subsequently, the releasingof the formulated prescription is based on any one, two, or three ofmatching of the intended recipient's fingerprint model with a currentlydetected fingerprint model, detection of environmental attributes withina pre-defined range, and/or matching of the intended recipient'scapacitive map with a currently detected capacitive map as describedabove.

The initial ID (e.g., of the processor 310) created for the COPA device100 can be a permanent ID for the COPA device 100. Informationassociated with the filled prescription may be associated with the ID ofthe COPA device 100 and recorded in the management system 950 and/or aninternal tracking system of the pharmacy 920. Thus, the COPA device 100is fully traceable through the creation and preparation path. Inaddition, the mold used to craft the COPA device 100 may be assignedwith a mold ID and may be stored in the management system 950 inassociation with the ID of the processor 310. Protocols for the use ofthe stored molds may be documented and records of subsequent mouthpiecesmay be stored in association in the management system 950. As such,misuse or fraud may be traced via the management system 950.

The pharmacy staff may pair the COPA device 100 with the docking station400. The pharmacy staff may record an ID of the docking station 400 inassociation with the COPA device 100 in the management system 950. Thewireless transceiver 420 of the docking station 400 may be recorded andregistered in the management system 950 for remote access to theprocessor 310 embedded in the COPA device 100. For example, a pharmacystaff may adjust the dosage of the filled prescribed medication based onthe instructions or an order of the prescribing doctor 910 by accessingthe processor 310 via the wireless transceiver 420 without the patientreturning the mouthpiece to the pharmacy 920 prior to depletion of theactive ingredient(s). The adjustment may allow for a limited number ofrevisions, for example, to the dosing amount per release, the timing ofthe release, and/or suspension of one or more of the chambers 322. Whilethe embodiment in FIG. 26 illustrates the docking station 400 inassociation with the COPA device 100, in other embodiments, the housing500 may be in association with the COPA device 100. For example, thepharmacy staff may pair the COPA device 100 with the housing 500, andthe pharmacy staff may record an ID of the housing 500 in associationwith the COPA device 100 in the management system 950.

The patient may pick up the COPA device 100 and the docking station 400from the pharmacy 920 and the pharmacy staff may provide instructions ofusage to the patient. The patient may insert the COPA device 100 intothe patient's mouth and close the mouth to bite on the COPA device 100so that the prescription dispensing unit 120 or the micro-pump unit 300may release the prescribed medication for ingestion. The patient mayclean the COPA device 100 and dock the COPA device 100 at the dockingstation 400 after use.

The patient and/or the authorized care giver may have access to anonline COPA account, for example, hosted on the management system 950via the network 940. The wireless transceiver 420 may detect andtransmit data such as activities recorded by the mouthpiece (e.g.,dispensing dosages and timings for each medication) to the managementsystem 950. The patient may view records of medications loaded into eachchamber 322 of the COPA device 100. The patient may view records of theadministration path of medications filled in the COPA device 100including the initial prescription and any subsequent revisions. Thepatient may view records of an anticipated depletion timeline for thepatient to pick up a second pre-filled COPA device (e.g., the COPAdevice 100) and drop off the depleted COPA device if the treatment is arecurring treatment.

In an embodiment, the refill process for the COPA device 100 may usesimilar policies as today's drug refill policies. The COPA device 100may be used in prolonged treatment plans. A prescribing doctor 910 mayadjust and revise the prescription based on the treatment resultsobserved from the patient. The doctor 910 may electronically transferthe revised prescription to the pharmacy 920. The pharmacy staff or thefulfillment technician may send revised instructions to the processor310 wirelessly through the wireless transceiver 420 of the dockingstation 400. The management system 950 may house a full record of allrevisions. When the intended recipient has depleted the COPA as planned,or as revised, the COPA device 100 may be returned to the pharmacy 920for refills, for example, as directed by the prescribing doctor 910. Thepharmacy staff may flush saline solution into the COPA device 100through the access ports 122 into the sealed prescription dispensingunit 120 and out the exit valves 222. After flushing the COPA device100, the pharmacy staff may refill the COPA device 100 based on theorder received from the doctor 910 and may update the record in themanagement system 950. For example, if a prescription is written forthree refills, the record would indicate three dosage IDs in associationwith the ID of the processor 310 of the COPA device 100 and previousdosage IDs. By recording all information associated with the COPA device100, the patient and the dosage information in the management system 950may be retrieved at any time, including when the patient changesproviders or pharmacies during a treatment plan.

In an embodiment, when the COPA device 100 is no longer needed, forexample, at the end of a treatment plan or change of treatment plan, theCOPA device 100 may be deactivated and the management system 950 may beupdated to indicate the deactivation of the COPA device 100. In someembodiments, when deactivation time of the COPA device 100 is within acertain time limit, for example, X number of months, an assemblytechnician may reuse the original impression to build a new COPA device100. The ID of the processor 310 within the new COPA device 100 may bestored in the management system 950 in association with the old ID ofthe old COPA device 100. In an embodiment, when a COPA device 100 needsto be recast due to actual change in the dentition of a recipient, thecreation and preparation processes described above may be repeated.Information associated with the new mold may be stored on the managementsystem 950 in association with the patient and the prescribedmedications. By tracking all COPA devices 100 associated with aparticular patient or a particular prescription, it may be less likelyfor an unintended user to gain access to the prescribed medications orfor an intended user to provide false information for misuse ofprescribed substances.

FIG. 27 is a flow diagram of a method 1000 of dispensing a substance toan intended user according to embodiments of the present disclosure. Themethod 1000 can be better understood with reference to FIGS. 23 and 24 .As illustrated, the method 1000 includes a number of enumerated steps,but embodiments of the method 1000 may include additional steps before,after, and in between the enumerated steps. In some embodiments, one ormore of the enumerated steps may be omitted or performed in a differentorder.

At step 1002, the method 1000 includes receiving an input from acapacitive sensor array of a mouthpiece. The capacitive sensor array maybe the top side capacitive sensor array 716 and/or the bottom sidecapacitive sensor array 718. The mouthpiece may be the COPA device 100.In some embodiments, the input may be generated by the top sidecapacitive sensor array 716 and/or the bottom side capacitive sensorarray 718, and then the input may be received by the processor 310.

At step 1004, the method 1000 includes determining, based on thereceived input, whether an intended user's unique dentition ispositioned within a recess of the mouthpiece. In some embodiments, theprocessor 310 may determine whether an intended user's unique dentitionis positioned within a recess (e.g., the recess 110) of the mouthpiece(e.g., the COPA device 100). For example, the processor 310 may comparea capacitive map associated with the input to a predetermined capacitivemap associated with the intended user's unique dentition to determinewhether there is a match between the current user of the COPA device 100and the intended user of the COPA device 100.

At step 1006, the method 1000 includes dispensing a substance from areservoir to a mouth of the intended user in response to determiningthat the intended user's unique dentition is positioned within therecess of the mouthpiece. In some embodiments, the reservoir (e.g., thereservoir 320) may be positioned outside the mouth. Therefore, thesubstance may be dispensed from outside the mouth. In other embodiments,the reservoir (e.g., the reservoir 320) may be positioned within themouth. Therefore, the substance may be dispensed from inside the mouth.

FIG. 28 is a flow diagram of a method 1100 of registering a substancedispensing apparatus to an intended user. The method 1100 can be betterunderstood with reference to FIGS. 3, 23, and 24 . As illustrated, themethod 1100 includes a number of enumerated steps, but embodiments ofthe method 1100 may include additional steps before, after, and inbetween the enumerated steps. In some embodiments, one or more of theenumerated steps may be omitted or performed in a different order.

At step 1102, the method 1100 includes receiving, from a capacitivesensor array of a mouthpiece, an input associated with an intendeduser's unique dentition biting on the mouthpiece. The capacitive sensorarray may be the top side capacitive sensor array 716 and/or the bottomside capacitive sensor array 718. The mouthpiece may be the COPA device100. In some embodiments, the received input is representative of acapacitive map of the intended user's unique dentition. Therefore, in anexemplary embodiment, the method 1100 may comprise receiving, from acapacitive sensor array of the mouthpiece, a capacitive map of theintended user's unique dentition, wherein the capacitive map may begenerated based on the intended user's unique dentition biting on themouthpiece. Additionally, in some embodiments, multiple inputs may bereceived to define a range of acceptable matches associated with theintended user's unique dentition.

In some embodiments, the method 1100 may further include a step ofstoring the received input in memory integrated in the substancedispensing apparatus. The memory may be memory 370 (which is discussedin greater detail above with respect to FIG. 7 ).

At step 1104, the method 1100 includes registering, based on thereceived input, the intended user to the mouthpiece. In someembodiments, the processor 310 may register the intended user to themouthpiece (e.g., the COPA device 100). In some embodiments, the step ofregistering the intended user to the mouthpiece may be the first actiontaken after the mouthpiece is manufactured. In other embodiments, theintended user may be the first person to wear the mouthpiece after themouthpiece is manufactured.

FIG. 29 is a flow diagram of a method 1200 of dispensing a substance toan intended user according to embodiments of the present disclosure. Themethod 1200 can be better understood with reference to FIGS. 9, 12, 23,and 24 . As illustrated, the method 1200 includes a number of enumeratedsteps, but embodiments of the method 1200 may include additional stepsbefore, after, and in between the enumerated steps. In some embodiments,one or more of the enumerated steps may be omitted or performed in adifferent order.

At step 1202, the method 1200 includes receiving an input from abiometric sensor. The biometric sensor may be the biometric sensor 550.In some embodiments, the input may be generated by the biometric sensor550, and then the input may be received by the processor 310. In someinstances, the input may be received when the intended user places atleast one of the intended user's fingers on the biometric sensor 550.

At step 1204, the method 1200 includes determining, based on thereceived input from the biometric sensor, whether the intended user'sunique biometric attribute is detected by the biometric sensor. In someembodiments, the processor 310 may determine whether an intended user'sunique fingerprint model is positioned on a biometric sensor (e.g., thebiometric sensor 550) of the housing 500. For example, the processor 310may compare a fingerprint model associated with the input to apredetermined fingerprint model associated with the intended user todetermine whether there is a match between the current user of thehousing 500 and the intended user of the housing 500. In some instances,the user's unique biometric attribute is detected by the biometricsensor 550 when the user's unique biometric attribute is positioned onthe biometric sensor 550. In other examples, the user's unique biometricattribute is detected by the biometric sensor 550 when the user's uniquebiometric attribute is spaced from the biometric sensor 550.

At step 1206, the method 1200 includes receiving an input from anenvironmental sensor. The environmental sensor may be the environmentalsensor 560. In some embodiments, the input may be generated by theenvironmental sensor 560, and then the input may be received by theprocessor 310.

At step 1208, the method 1200 includes determining, based on thereceived input from the environmental sensor, whether the mouthpiece ispositioned within the user's mouth. In some embodiments, the processor310 may determine whether the mouthpiece (e.g., the COPA device 100), ispositioned within the user's mouth. For example, the processor 310 maycompare an environmental attribute associated with the input to apre-defined range of environmental attributes to determine whether thecurrent environmental attribute is within the pre-defined range ofenvironmental attributes. In some embodiments, when the currentenvironmental attribute is within the pre-defined range of environmentalattributes, the processor 310 may determine that the mouthpiece (e.g.,the COPA device 100) is positioned within the user's mouth.

At step 1210, the method 1200 includes receiving an input from acapacitive sensor array of a mouthpiece. The capacitive sensor array maybe the top side capacitive sensor array 716 and/or the bottom sidecapacitive sensor array 718. The mouthpiece may be the COPA device 100.In some embodiments, the input may be generated by the top sidecapacitive sensor array 716 and/or the bottom side capacitive sensorarray 718, and then the input may be received by the processor 310.

At step 1212, the method 1200 includes determining, based on thereceived input from the capacitive sensor array, whether the intendeduser's unique dentition is positioned within a recess of the mouthpiece.In some embodiments, the processor 310 may determine whether theintended user's unique dentition is positioned within a recess (e.g.,the recess 110) of the mouthpiece (e.g., the COPA device 100). Forexample, the processor 310 may compare a capacitive map associated withthe input to a predetermined capacitive map associated with the intendeduser's unique dentition to determine whether there is a match betweenthe current user of the COPA device 100 and the intended user of theCOPA device 100.

At step 1214, the method 1200 includes dispensing a substance from areservoir to a mouth of the intended user in response to determiningthat the intended user's unique biometric attribute is detected by thebiometric sensor, that the mouthpiece is positioned within the user'smouth, and/or that the intended user's unique dentition is positionedwithin the recess of the mouthpiece. In some embodiments, the method1200 can include any one, two, and/or three of the steps describedabove. Thus, step 1214 may be performed by any combination of steps1202/1204, steps 1206/1208, and/or steps 1210/1212. In some embodiments,the reservoir (e.g., the reservoir 320) may be positioned outside themouth. Therefore, the substance may be dispensed from outside the mouth.In other embodiments, the reservoir (e.g., the reservoir 320) may bepositioned within the mouth. Therefore, the substance may be dispensedfrom inside the mouth.

FIG. 30 is a flow diagram of a method 1300 of registering a substancedispensing apparatus and/or a housing to an intended user. The method1300 can be better understood with reference to FIGS. 3, 9, 23, and 24 .As illustrated, the method 1300 includes a number of enumerated steps,but embodiments of the method 1300 may include additional steps before,after, and in between the enumerated steps. In some embodiments, one ormore of the enumerated steps may be omitted or performed in a differentorder.

At step 1302, the method 1300 includes receiving, from a biometricsensor of a housing, an input associated with an intended user's uniquebiometric attribute contacting the housing. The biometric sensor may bethe biometric sensor 550, and the housing may be the housing 500. Insome embodiments, the received input is representative of the intendeduser's unique fingerprint model. Therefore, in an exemplary embodiment,the method 1300 may comprise receiving, from a biometric sensor of thehousing, the intended user's fingerprint model, wherein the intendeduser's fingerprint model may be generated based on the intended user'sfingerprint contacting the biometric sensor. Additionally, in someembodiments, multiple inputs from the biometric sensor may be receivedto define a range of acceptable matches associated with the intendeduser's unique fingerprint model. In some embodiments, the method 1300may further include a step of storing the received input from thebiometric sensor in memory integrated in the housing. In someembodiments, the biometric attribute may not contact the housing 500.

At step 1304, the method 1300 includes registering, based on thereceived input from the biometric sensor, the intended user to thehousing. In some embodiments, the processor 310 may register theintended user to the housing (e.g., the housing 500). In someembodiments, the step of registering the intended user to the housingmay be the first action taken after the housing is manufactured. Inother embodiments, the intended user may be the first person to touchthe biometric sensor after the housing is manufactured.

At step 1306, the method 1300 includes receiving, from a capacitivesensor array of a mouthpiece, an input associated with an intendeduser's unique dentition biting on the mouthpiece. The capacitive sensorarray may be the top side capacitive sensor array 716 and/or the bottomside capacitive sensor array 718. The mouthpiece may be the COPA device100. In some embodiments, the received input is representative of acapacitive map of the intended user's unique dentition. Therefore, in anexemplary embodiment, the method 1300 may comprise receiving, from acapacitive sensor array of the mouthpiece, a capacitive map of theintended user's unique dentition, wherein the capacitive map may begenerated based on the intended user's unique dentition biting on themouthpiece. Additionally, in some embodiments, multiple inputs may bereceived to define a range of acceptable matches associated with theintended user's unique dentition. In some embodiments, the receivedinput from the capacitive sensor array of the mouthpiece is associatedwith an intended user's unique dentition being within the mouthpiece.

In some embodiments, the method 1300 may further include a step ofstoring the received input in memory integrated in the substancedispensing apparatus. The memory may be memory 370 (which is discussedin greater detail above with respect to FIG. 7 ).

At step 1308, the method 1300 includes registering, based on thereceived input from the capacitive sensor array, the intended user tothe mouthpiece. In some embodiments, the processor 310 may register theintended user to the mouthpiece (e.g., the COPA device 100). In someembodiments, the step of registering the intended user to the mouthpiecemay be the first action taken after the mouthpiece is manufactured. Inother embodiments, the intended user may be the first person to wear themouthpiece after the mouthpiece is manufactured. In still otherinstances, the step of registering the intended user to the mouthpiecemay occur simultaneously with the step of registering the intended userto the housing. In various other examples, the step of registering theintended user to the mouthpiece may occur separately from the step ofregistering the intended user to the housing. For example, the method1300 may include performing steps 1302/1304 and then later performingsteps 1306/1308. In other examples, the method 1300 may includeperforming steps 1306/1308 and then later performing steps 1302/1304. Insome embodiments, the step of registering the intended user to themouthpiece and the step of registering the intended user to the housingmay occur as part of the process of a patient being prescribedmedication, which is discussed above with respect to FIG. 29 .

The following table lists reference numerals and corresponding referencenames:

TABLE 1 Reference Numerals and Corresponding Reference Names. ReferenceNumerals Reference Names 100 COPA device 102 top side 104 bottom side110 recess 114 compartment 120 prescription dispensing unit 122 accessports 124 sleeve 126 front wall portion 127 outer face of front wall 128back wall portion 129 outer face of back wall 130 cutout portion 134access opening 210 recess 222 exit valves 300 micro-pump unit 310processor 320 reservoir 322 chambers 330 actuator 340 exit valves 350flow channels 360 component 370 memory 380 wireless transceiver 400docking station 410 docking compartment 420 wireless transceiver 430component 440 indicators 450 COPA device sensing component 500 housing510 upper portion 520 lower portion 522 front face 524 front wall 530docking port 532 exit port 540 tubular member 550 biometric sensor 560environmental sensor 570 bottom wall 580 tubular connector 590medication bottle 591 base of medication bottle 592 cap 594 dip tube 596valve 598 pump 600 distal end of dip tube 602 proximal end of dip tube604 distal end of valve 606 proximal end of valve 608 distal end oftubular connector 610 proximal end of tubular connector 612 distal endof pump 614 proximal end of pump 616 distal end of tubular member 618proximal end of tubular member 702 base layer 706 top side intermediatelayer 708 bottom side intermediate layer 710 wire 712 top side outerlayer 714 bottom side outer layer 716 top side capacitive sensor array718 bottom side capacitive sensor array 720 prescribed substance 722upper teeth 724 lower teeth 726 upper tooth 728 structural feature 730access cannulas 740 exit cannulas 900 system 910 doctor 920 pharmacy 930patient/authorized caregiver portal 940 network 950 COPA managementsystem

Persons skilled in the art will recognize that the apparatus, systems,and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. A substance dispensing apparatus, comprising: ahousing sized and shaped for handheld use, the housing comprising abiometric sensor and a cavity sized and shaped to receive a reservoir; amouthpiece coupled to the housing, the mouthpiece comprising a recessand a capacitive sensor array; a pump coupled to the mouthpiece andcouplable to the reservoir; and a processor in communication with thebiometric sensor, the capacitive sensor array, and the pump, theprocessor configured to: cause the pump to automatically dispense asubstance from the reservoir to a mouth of an intended user via themouthpiece in response to determining that: a unique biometric attributeof the intended user is detected by the biometric sensor based onbiometric data from the biometric sensor; and a unique dentition of theintended user is positioned within the recess of the mouthpiece based ondentition data from the capacitive sensor array.
 2. The substancedispensing apparatus of claim 1, wherein the biometric sensor includes afingerprint sensor.
 3. The substance dispensing apparatus of claim 2,wherein the biometric data from the biometric sensor includesfingerprint data, and wherein determining whether the unique biometricattribute of the intended user is detected by the biometric sensorincludes: comparing the fingerprint data to a plurality of predeterminedfingerprint models associated with the unique biometric attribute of theintended user; and determining that the fingerprint data matches atleast one predetermined fingerprint model of the plurality ofpredetermined fingerprint models.
 4. The substance dispensing apparatusof claim 3, wherein the predetermined fingerprint models of theplurality of predetermined fingerprint models associated with theintended user define a range of acceptable fingerprint model matchesassociated with the intended user.
 5. The substance dispensing apparatusof claim 1, wherein the housing includes at least one wall, and whereinthe biometric sensor is coupled to the at least one wall.
 6. Thesubstance dispensing apparatus of claim 1, wherein the cavity is sizedand shaped to receive a pharmaceutical medication bottle configured tohold a liquid.
 7. The substance dispensing apparatus of claim 1, whereinthe cavity is sized based on a volume of the substance contained by thereservoir.
 8. The substance dispensing apparatus of claim 1, wherein thesubstance is an opioid.
 9. The substance dispensing apparatus of claim1, wherein the pump is positioned within the housing.
 10. The substancedispensing apparatus of claim 1, wherein the dentition data from thecapacitive sensor array includes a capacitive map, and whereindetermining whether the unique dentition of the intended user ispositioned within the recess of the mouthpiece: comparing the capacitivemap to a plurality of predetermined capacitive maps associated with theunique dentition of the intended user; and determining that thecapacitive map matches at least one predetermined capacitive map of theplurality of predetermined capacitive maps.
 11. The substance dispensingapparatus of claim 10, wherein the predetermined capacitive maps of theplurality of predetermined capacitive maps associated with the uniquedentition of the intended user define a range of acceptable capacitivemap matches associated with the unique dentition of the intended user.12. The substance dispensing apparatus of claim 1, further comprising acap, wherein the pump is couplable to the reservoir via the cap.
 13. Thesubstance dispensing apparatus of claim 12, wherein the cap comprisesthreads, and wherein the reservoir comprises grooves configured toreceive the threads to couple the cap and the reservoir.
 14. Thesubstance dispensing apparatus of claim 12, wherein the cap comprises: avalve; and a dip tube coupled to the valve, wherein the valve isconfigured to regulate an amount of the substance extracted from thereservoir and supplied to the pump.
 15. The substance dispensingapparatus of claim 1, wherein the housing is configured to releasablyseal the reservoir within the cavity.
 16. The substance dispensingapparatus of claim 1, wherein the pump is coupled to the mouthpiece viaa tubular member; and further comprising: a valve, wherein the valve isconfigured to control a flow of the substance to the intended user. 17.The substance dispensing apparatus of claim 1, wherein the processor isfurther configured to: register, based on the biometric data from thebiometric sensor, the intended user to the housing; and store thebiometric data from the biometric sensor in memory coupled to thehousing.
 18. The substance dispensing apparatus of claim 1, wherein theprocessor is further configured to register, based on the dentition datafrom the capacitive sensor array, the intended user to the mouthpiece.19. The substance dispensing apparatus of claim 1, wherein the processoris further configured to store dosage information for a prescriptionassociated with the intended user in memory coupled to the housing. 20.The substance dispensing apparatus of claim 19, wherein the substance isconfigured to be dispensed based on the dosage information.
 21. Thesubstance dispensing apparatus of claim 20, wherein the substance is anopioid.